Clinical trials: Renal Insufficiency
End Stage Renal Disease
Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects
This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy subjects and patients with End Stage Renal Disease on hemodialysis.
- Trial name
- NCT01568775
- Testing
- Aliskiren
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis
Secondary Hyperparathyroidism, End Stage Renal Disease
Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term haemodialysis treatment.
- Conditions
- Secondary Hyperparathyroidism, End Stage Renal Disease, Parathyroid Hyperplasia
- Trial name
- NCT01421407
- Testing
- Ultrasonic ablation device
- Where
- 3 sites in Italy, Spain
- Sponsor
- Theraclion
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
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT03893799
- Testing
- RBT-1
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Anemia
FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease
This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.
- Trial name
- NCT02652806
- Testing
- FG-4592, Epoetin Alfa
- Where
- 31 sites in China
- Volunteers
- 305 people
- Sponsor
- Kyntra Bio
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
Relapsed Multiple Myeloma, End-stage Renal Disease
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease
The purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Trial name
- NCT01949532
- Testing
- Carfilzomib
- Where
- 13 sites in United States, Australia and 1 more
- Volunteers
- 26 people
- Sponsor
- Amgen
Hypertension With Moderate Renal Impairment
Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment
To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.
- Trial name
- NCT02807987
- Testing
- CS-3150
- Where
- Japan
- Volunteers
- 58 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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.
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
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.
This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Renal Impaired
- Trial name
- NCT01555866
- Testing
- isavuconazole
- Where
- 3 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Type 2 Diabetes Mellitus, Chronic Kidney Disease
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to…
- Trial name
- CONFIDENCE (NCT05254002)
- Testing
- Finerenone (BAY94-8862 ) 10 mg, Empagliflozin, Finerenone (BAY94-8862 ) 20 mg
- Where
- 173 sites in United States, Belgium and 12 more
- Volunteers
- 1,664 people
- Sponsor
- Bayer
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
Renal Impairment, Type 2 Diabetes Mellitus
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with…
- Trial name
- NCT01948986
- Testing
- Ertugliflozin
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Anemia, Dialysis-dependent Chronic Kidney Disease
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
- Trial name
- FO2RWARD-2 (NCT03799627)
- Testing
- Vadadustat, Epoetin Alfa, Vadadustat TIW
- Where
- 41 sites in United States
- Volunteers
- 175 people
- Sponsor
- Akebia Therapeutics
Renal Insufficiency
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal…
- Trial name
- NCT02894905
- Testing
- AL-335
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
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
Uncontrolled Hypertension
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.
- Trial name
- HD (NCT05352425)
- Testing
- MobiusHD
- Sponsor
- Vascular Dynamics, Inc.
Chronic Obstructive Pulmonary Disease
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same…
- Trial name
- NCT05431426
- Testing
- CH6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Renal Insufficiency, Renal Impairment
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with…
- Trial name
- NCT02011490
- Testing
- sugammadex
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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