Clinical trials: Severe Functional Impairment
Neoplasm Malignant
Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment
Primary Objective: To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel Secondary Objective: To assess the safety of cabazitaxel in patients with various degrees of renal…
- Trial name
- NCT01527929
- Testing
- Cabazitaxel XRP6258
- Where
- 7 sites in Belgium, Italy and 3 more
- Volunteers
- 25 people
- Sponsor
- Sanofi
Aortic Stenosis, Left Ventricular Function Systolic Dysfunction
Transcatheter Aortic Valve Implantation Without Predilation
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely…
- Conditions
- Aortic Stenosis, Left Ventricular Function Systolic Dysfunction, High-risk Patients, Transcatheter Aortic Valve Implantation
- Trial name
- SIMPLIFy TAVI (NCT01539746)
- Testing
- TAVI without BAV, TAVI standard procedure
- Where
- 6 sites in Germany
- Volunteers
- 110 people
- Sponsor
- University Hospital, Bonn
Hepatitis B Virus
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe…
- Trial name
- NCT02296853
- Testing
- TAF
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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
Obesity
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism.
- Trial name
- NCT00472836
- Testing
- CP-945,598
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.
- Trial name
- NCT01443429
- Testing
- beraprost sodium(BPS)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Toray Industries, Inc
Hepatic Insufficiency
A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver.
- Trial name
- NCT07401862
- Testing
- LY3841136
- Where
- 3 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Insufficiency, Blood Coagulation Disorders
Major Liver Resection: Early Clotting Disorders and Functional Impairment.
The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver…
- Trial name
- NCT02813538
- Testing
- Indocyanine green clearance, Thromboelastometry
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
Renal Insufficiency, Kidney Disease
A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.
The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end…
- Trial name
- NCT02325024
- Testing
- Sativex
- Volunteers
- healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Renal Insufficiency
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam.
- Trial name
- NCT04486625
- Testing
- Aztreonam-Avibactam
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pharmacokinetics, Renal Impaired
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
- Conditions
- Pharmacokinetics, Renal Impaired, Healthy Volunteer
- Trial name
- NCT01569828
- Testing
- LCZ696A
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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 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
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Cirrhosis, Alcoholism
Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
- Trial name
- NCT00698464
- Testing
- Pasireotide
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
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
Diabetes
Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment
This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.
- Trial name
- NCT07193147
- Testing
- GZR4
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
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
Multiple Myeloma, Renal Impairment
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and…
- Trial name
- POM Renal (NCT01575925)
- Testing
- 4 mg Oral POM + 40 mg Oral DEX, 2 mg Oral POM + 40 mg Oral DEX
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Celgene