alanine and Renal Insufficiency

alanine has been researched along with Renal Insufficiency in 9 studies

Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.

Renal Insufficiency: Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.

Research

Studies (9)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Change From Baseline in eGFR-CG at Week 96

"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 96 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 96

Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48

"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 48 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 48

Change From Baseline in FibroTest® Score at Week 48

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 48

Change From Baseline in FibroTest® Score at Week 96

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Percentage of Participants With HBeAg Loss at Week 96

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBeAg Seroconversion at Week 48

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBeAg Seroconversion at Week 96

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBsAg Loss at Week 96

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBsAg Seroconversion at Week 48

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBsAg Seroconversion at Week 96

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis. (NCT02979613)
Timeframe: Weeks 48

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96

The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm

"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 96 analysis window and~Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 96

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 48 analysis window and~Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96

The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96

Change From Baseline in CD4 Cell Count at Week 48

(NCT02469246)
Timeframe: Baseline; Week 48

Change From Baseline in CD4 Cell Count at Week 96

(NCT02469246)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip BMD at Week 96

(NCT02469246)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

(NCT02469246)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 48

(NCT02469246)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 96

(NCT02469246)
Timeframe: Baseline; Week 96

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Change From Baseline in CD4+ Cell Count at Week 144

(NCT02607956)
Timeframe: Baseline, Week 144

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02607956)
Timeframe: Baseline, Week 48

Change From Baseline in CD4+ Cell Count at Week 48 Open-Label

(NCT02607956)
Timeframe: Baseline, open-label Week 48

Change From Baseline in CD4+ Cell Count at Week 96

(NCT02607956)
Timeframe: Baseline, Week 96

Change From Baseline in CD4+ Cell Count at Week 96 Open-Label

(NCT02607956)
Timeframe: Baseline, open-label Week 96

Change From Baseline in log10 HIV-1 RNA at Week 144

(NCT02607956)
Timeframe: Baseline, Week 144

Change From Baseline in log10 HIV-1 RNA at Week 48

(NCT02607956)
Timeframe: Baseline, Week 48

Change From Baseline in log10 HIV-1 RNA at Week 96

(NCT02607956)
Timeframe: Baseline, Week 96

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 144

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 48

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 96

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 144

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 48

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit. (NCT02607956)
Timeframe: Baseline, open-label Week 48

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607956)
Timeframe: Baseline, open-label Week 48

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 96

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit. (NCT02607956)
Timeframe: Baseline, open-label Week 96

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607956)
Timeframe: Baseline, open-label Week 96

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 96

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 96

Change From Baseline in CD4 Cell Count at Weeks 96

The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. (NCT01815736)
Timeframe: Baseline; Week 96

Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. (NCT01815736)
Timeframe: Baseline; Week 48

Change From Baseline in Serum Creatinine at Week 48

(NCT01815736)
Timeframe: Baseline; Week 48

Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48

"The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement.~EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit." (NCT01815736)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented. (NCT01815736)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented. (NCT01815736)
Timeframe: Baseline; Week 48

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 48

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 48

Reviews

3 reviews available for alanine and Renal Insufficiency

Trials

1 trial available for alanine and Renal Insufficiency

Other Studies

5 other studies available for alanine and Renal Insufficiency