Clinical trials: Functional Insufficiency
Hepatic Encephalopathy
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
- Trial name
- NCT04128462
- Testing
- MNK-6105, Standard of Care
- Sponsor
- Mallinckrodt
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Pre-Eclampsia, Hypertension
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Whole blood sample procurement study from pregnant women with signs and symptoms of Preeclampsia.
- Conditions
- Pre-Eclampsia, Hypertension, Proteinuria in Pregnancy, Thrombocytopenia
- Trial name
- NCT03767803
- Testing
- Non-interventional study
- Where
- 24 sites in United States
- Volunteers
- 344 people
- Sponsor
- Progenity, Inc.
Healthy, Renal Insufficiency
A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function
The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy…
- Trial name
- NCT05469100
- Testing
- Selpercatinib
- Where
- 6 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Obesity/Overweight
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or…
- Trial name
- NCT07144098
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Renal Impairment
A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment
The purpose of this study is to assess the effect of varying degrees of renal impairment (mild, moderate, severe and end stage renal disease) compared with subjects with normal renal function on the pharmacokinetics of the…
- Trial name
- NCT01319266
- Testing
- Hydrocodone Bitartrate extended-release tablet
- Where
- 4 sites in United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Cephalon
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes Mellitus, Type 2, Impaired Renal Function
Dapagliflozin Treatment in Type 2 Diabetes
Open label, mechanistic, single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function.
- Trial name
- NCT04620590
- Testing
- Dapagliflozin 10 MG [Farxiga]
- Where
- 2 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Emerald Clinical Inc.
Ischemic Mitral Regurgitation, Functional Mitral Regurgitation
Epicardial Mitral Touch System for Mitral Insufficiency
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic…
- Trial name
- ENRAPTUS (NCT04396379)
- Testing
- Implant an epicardial device to reshape the mitral valve annulus
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mitre Medical Corp.
Renal Impairment
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild…
- Trial name
- NCT03159416
- Testing
- Inclisiran
- Where
- 2 sites in New Zealand
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Medicines Company
Functional Mitral Regurgitation, Mitral Regurgitation
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
- Trial name
- ACTIVE (NCT03016975)
- Testing
- Edwards Cardioband System, Guideline Directed Medical Therapy
- Where
- 24 sites in United States
- Volunteers
- 12 people
- Sponsor
- Edwards Lifesciences
Chronic Kidney Disease
Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment
Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to…
- Trial name
- NCT04820621
- Testing
- Runcaciguat (BAY1101042)
- Where
- Germany
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Impairment, Healthy
A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment
The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants.
- Conditions
- Renal Impairment, Healthy, Renal Insufficiency, End Stage Renal Disease (ESRD)
- Trial name
- NCT07165015
- Testing
- LY3537031
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Impairment, Renal Disease
Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function
Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal…
- Trial name
- NCT04810598
- Testing
- Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AbbVie
Chronic Kidney Disease
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
The purpose of this study is to characterize the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal…
- Trial name
- NCT02756520
- Testing
- Observational study: Supplemented protein-restricted diet
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Fresenius Kabi
Normal and Impaired Renal Function
A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7…
- Trial name
- NCT02436447
- Testing
- MTP-131
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Stealth BioTherapeutics Inc.
Hepatic Insufficiency, Renal Insufficiency
Study of Copanlisib in Hepatic or Renal Impairment
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
- Trial name
- NCT03172884
- Testing
- Copanlisib (ALIQOPA, BAY80-6946)
- Where
- 2 sites in Germany, Romania
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatitis B
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood.
- Trial name
- B-Kind (NCT07168356)
- Testing
- Bepirovirsen
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Renal Impairment
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
Primary Objective: To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects Secondary Objective: To assess the…
- Trial name
- NCT01239459
- Testing
- Teriflunomide HMR1726, Cholestyramine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- Sanofi
Renal Impairment, Healthy Participants
Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function
The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired renal function compared to matched control subjects with normal renal function
- Trial name
- NCT03961932
- Testing
- Linzagolix
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ObsEva SA