Clinical trials: Functional Insufficiency
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package…
- Trial name
- NCT00584779
- Testing
- Gabapentin
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Renal Impairment
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring…
- Trial name
- NCT07217886
- Testing
- S-892216-PO
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shionogi
Glomerulonephritis
Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency
The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function.
- Trial name
- NCT05505955
- Testing
- HRS-5965
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment
This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic…
- Trial name
- NCT07550634
- Testing
- MDR-001
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- MindRank AI Ltd
Renal Impairment
Study Of Palbociclib (PD-0332991) In Renal Impairment
Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib.
- Trial name
- NCT02085538
- Testing
- palbociclib
- Where
- 3 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Insufficiency
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function
- Trial name
- NCT02320045
- Testing
- ITCA 650 (Exenatide in osmotic mini pump)
- Where
- 4 sites in United States, Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Intarcia Therapeutics
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.
Mitral Regurgitation, Mitral Valve Regurgitation
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation
- Trial name
- CINCH-2 (NCT00800046)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Ancora Heart, Inc.
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
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Acute Kidney Injury, Renal Insufficiency
A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function
The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are.
- Trial name
- NCT07368712
- Testing
- No investigational study intervention
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- Bayer
Mitral Valve Regurgitation (Degenerative or Functional)
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Trial name
- NCT02718001
- Testing
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Where
- 19 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Edwards Lifesciences
Hepatic Failure
Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function. 2.
- Trial name
- NCT00831532
- Testing
- Dimebon
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid…
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT-II (NCT03225612)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in Germany, Italy and 2 more
- Volunteers
- 60 people
- Sponsor
- Mitralign, Inc.
Renal Insufficiency, Healthy
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects
- Trial name
- NCT04024332
- Testing
- ACT-541468
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy, Hepatic Insufficiency
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
- Trial name
- NCT02334800
- Testing
- Palbociclib 75 mg Capsule
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Kidney Disease
Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound.
- Trial name
- NCT05425719
- Testing
- MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 8 sites in United States, China
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Renal Impairment
Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment
To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with severe renal impairment and end stage renal disease not on dialysis.
- Trial name
- NCT02852239
- Testing
- dabrafenib
- Where
- 3 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
- Trial name
- NCT06212193
- Testing
- Trillium™
- Where
- 12 sites in United States, Germany
- Volunteers
- 15 people
- Sponsor
- Innoventric LTD