Clinical trials: Severe Functional Impairment
Solid Tumours
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function
- Trial name
- NCT02923947
- Testing
- Osimertinib; AZD9291
- Where
- 11 sites in France, South Korea and 1 more
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects…
- Trial name
- NCT00938158
- Testing
- albiglutide
- Where
- 7 sites in United States, South Africa
- Volunteers
- 75 people
- Sponsor
- GlaxoSmithKline
Renal Insufficiency
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.
- Trial name
- NCT03545087
- Testing
- Lanabecestat, Iohexol
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
- Trial name
- NCT03443063
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers, Polycystic Kidney, Autosomal Dominant
Effect of Venglustat in Patients With Renal Impairment
Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics (PK) of Venglustat following a single dose.
- Trial name
- NCT03687554
- Testing
- Venglustat GZ/SAR402671
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Renal Impairment
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects…
- Trial name
- NCT01763190
- Testing
- SAR302503
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Gaucher Disease
A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Primary Objective: To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat.
- Trial name
- NCT02536937
- Testing
- eliglustat
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Impairment
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
- Trial name
- NCT05078580
- Testing
- Iptacopan
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Severe Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic…
- Trial name
- NCT02170220
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Renal Impairment
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.
- Trial name
- NCT01082640
- Testing
- Febuxostat
- Where
- 58 sites in United States
- Volunteers
- 96 people
- Sponsor
- Takeda
Hepatitis C
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after…
- Trial name
- NCT01580306
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
Primary Objective: To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and…
- Trial name
- NCT01120314
- Testing
- OTAMIXABAN (XRP0673)
- Where
- 4 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Kidney Failure, Chronic, Healthy Volunteers
A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis
The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278.
- Conditions
- Kidney Failure, Chronic, Healthy Volunteers, Renal Impairment
- Trial name
- NCT06723535
- Testing
- BMS-986278
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy, Renal Impairment
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.
- Trial name
- NCT06352411
- Testing
- BI 456906
- Where
- 2 sites in Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Insufficiency
Afatinib in Subjects With Kidney Dysfunction
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal…
- Trial name
- NCT02096718
- Testing
- Afatinib healthy, Afatinib severe renally impaired, Afatinib moderate renally impaired
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatitis C
To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet
Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
- Trial name
- NCT02108639
- Testing
- DCV 3DAA FDC, BMS-791325
- Where
- 4 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Liver Dysfunction, Healthy Volunteers
An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage
The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.
- Trial name
- NCT03890809
- Testing
- BMS-986165
- Where
- 4 sites in Czechia, Hungary and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment…
- Trial name
- NCT02397707
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy, Chronic Kidney Disease
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 764198 is Processed in the Body
The main objective of this trial is to investigate the influence of moderate and severe renal impairment on the pharmacokinetics of a single dose of BI 764198 in comparison to a group of matched controls with normal renal…
- Trial name
- NCT04176536
- Testing
- BI 764198
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim