Clinical trials: Functional Insufficiency
Functional Tricuspid Regurgitation, Heart Valve Diseases
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with…
- Conditions
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- Trial name
- NCT03632967
- Testing
- Tricinch Coil System Implantation
- Where
- 9 sites in United States
- Volunteers
- 7 people
- Sponsor
- 4Tech Cardio Ltd.
Type 2 Diabetes Mellitus
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.
- Trial name
- NCT01316094
- Testing
- ASP1941
- Where
- 8 sites in Japan
- Volunteers
- 165 people
- Sponsor
- Astellas Pharma Inc
Chronic Kidney Disease
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy…
- Trial name
- NCT06039254
- Testing
- HRS-1780
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Renal Impairment
Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients
This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function
- Trial name
- NCT03506854
- Testing
- ISIS 681257
- Where
- 3 sites in United States, Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Akcea Therapeutics
Renal Failure
A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
- Trial name
- NCT04237831
- Testing
- BMS-986259
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Alzheimer Disease
Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects
- Trial name
- NCT02340195
- Testing
- Idalopirdine (Lu AE58054) 60 mg
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy Volunteers, Impaired Renal Function
RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal…
- Trial name
- NCT04252430
- Testing
- MD1003
- Where
- 5 sites in France, Hungary
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
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
Healthy Volunteers, Renal Impairment
A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05495581
- Testing
- pudexacianinium chloride
- Where
- 4 sites in United States, Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Mitral Valve Regurgitation
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Trial name
- MAVERIC (NCT02302872)
- Testing
- ARTO System
- Where
- 9 sites in Australia, France and 3 more
- Volunteers
- 51 people
- Sponsor
- Mvrx, Inc.
Chronic Renal Insufficiency
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the…
- Trial name
- STP237 (NCT05735951)
- Testing
- STIRIPENTOL oral administration
- Where
- Bulgaria
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Biocodex
Sickle Cell Disease (SCD)
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle…
- Trial name
- STEADFAST (NCT04053764)
- Testing
- Crizanlizuamb, Standard of Care
- Where
- 24 sites in United States, Brazil and 9 more
- Volunteers
- 58 people
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
PK in Patients With Various Degrees of Renal Impairment
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects
This is a Phase 1, multi-center, open-label, PK and safety study of a single dose of AAI101 in combination with cefepime in male and female subjects with mild renal impairment (Group 1, n = 6), moderate renal impairment (Group 2…
- Trial name
- NCT03680352
- Testing
- cefepime/AAI101
- Where
- 2 sites in Czechia, Hungary
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Allecra
Renal Impairment
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
This is an open-label, single dose study designed to assess the pharmacokinetics and safety of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal function.
- Trial name
- NCT02442258
- Testing
- ABT-493, ABT-530
- Where
- 3 sites in United States, New Zealand
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- AbbVie
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
Renal Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01770652
- Testing
- Deferiprone
- Where
- 2 sites in Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- ApoPharma
COVID-19
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
The purpose of the study is to learn about: how PF-07817883 is processed in the body of adult participants. the safety of PF-07817883.
- Trial name
- NCT06586216
- Testing
- PF-07817883
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer