Clinical trials: Functional Insufficiency
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Kidney Disease, Chronic
A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function…
- Trial name
- NCT05182840
- Testing
- BI 690517, Empagliflozin
- Where
- 203 sites in United States, Argentina and 27 more
- Volunteers
- 714 people
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer Study, Hepatic Impairment
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Conditions
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- Trial name
- NCT06911320
- Testing
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Renal Insufficiency
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With and Without Renal Impairment
To assess the effect of different degrees of renal impairment on the pharmacokinetics and pharmacodynamics of dabigatran etexilate administered orally.
- Trial name
- NCT02182024
- Testing
- Dabigatran etexilate high dose, Dabigatran etexilate low dose
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Kidney Failure, Chronic
A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function
The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring…
- Trial name
- NCT03546205
- Testing
- JNJ-64565111
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Human Immunodeficiency Virus (HIV) Infection
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.
- Trial name
- NCT00717067
- Testing
- Maraviroc, Ritonavir, Saquinavir
- Where
- 2 sites in Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Preeclampsia, Hypertension
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia
- Trial name
- NCT02780414
- Where
- 20 sites in United States
- Volunteers
- 1,730 people
- Sponsor
- Progenity, Inc.
Renal Insufficiency, Kidney Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Impaired Renal Function and Participants on Hemodialysis
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with impaired renal function and participants on hemodialysis.
- Trial name
- NCT07854249
- Testing
- INCB161734
- Volunteers
- 24 people
- Sponsor
- Incyte Corporation
Renal Impairment
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
- Trial name
- NCT01740362
- Testing
- CP-690,550
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched…
- Trial name
- NCT05497297
- Testing
- HSK7653 tablets
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Renal Impairment
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901.
- Trial name
- NCT02975388
- Testing
- RO7079901
- Where
- 5 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Renal Impairment
Glasdegib Renal Impairment Study
The goal of this study is to administer single dose (100 mg) glasdegib tablet to subjects with normal, moderate and severe renal impairment and estimate the effect, if any, of this renal impairment on glasdegib pharmacokinetics.
- Trial name
- NCT03596567
- Testing
- Glasdegib single 100 mg dose in normal healthy subjects, Glasdegib single 100 mg dose in moderate renal impairment subjects, Glasdegib single 100 mg dose in severe renal impairment subjects
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK…
- Trial name
- NCT04909853
- Testing
- PF-07321332/ritonavir
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Symptomatic Functional MR 3 or Greater
AMEND TS Early Feasibility Study
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation.
- Trial name
- NCT06951672
- Testing
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Valcare Medical Ltd.
Renal Impairment
A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function
The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal…
- Trial name
- NCT05940402
- Testing
- Emraclidine
- Where
- 5 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- AbbVie
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
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
Liver Cirrhosis, Liver Failure
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"
The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".
- Trial name
- NCT01201720
- Testing
- Plasma exchange with albumin
- Where
- Spain
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Instituto Grifols, S.A.
Renal Insufficiency, Healthy
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
- Trial name
- NCT03302091
- Testing
- BI 1467335
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim