Clinical trials: Impaired Renal Function
Heart Failure and Impaired Kidney Function
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event.
- Trial name
- BalanceD-HF (NCT06307652)
- Where
- 852 sites in United States, Argentina and 37 more
- Volunteers
- 3,850 people
- Sponsor
- AstraZeneca
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.
Renal Impaired, Gilteritinib
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal…
- Conditions
- Renal Impaired, Gilteritinib, Normal Renal Function, Pharmacokinetics of ASP2215
- Trial name
- NCT04699877
- Testing
- Gilteritinib
- Where
- 4 sites in United States, Bulgaria
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Patients With Impaired Renal Function
Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal Function
The objective of this study is to compare the pharmacokinetics of ASP015K in patients with impaired renal function and subjects with normal renal function.
- Trial name
- NCT02603497
- Testing
- ASP015K
- Where
- 2 sites in Japan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
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.
Impaired Renal Function
Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias.
- Trial name
- NCT01716455
- Testing
- SSP-004184
- Where
- 2 sites in United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Shire
Impaired Renal Function
A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function
- Trial name
- NCT03776539
- Testing
- ELX-02
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eloxx Pharmaceuticals, Inc.
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.
Normal Renal Function, Impaired Renal Function
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal…
- Trial name
- NCT02431481
- Testing
- LEE011
- Where
- 4 sites in United States, Bulgaria and 2 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Metastatic Cancer With Impaired Renal Function, Metastatic Cancer With Normal Renal Function
An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404
The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.
- Trial name
- NCT01240642
- Testing
- ASA404
- Where
- 4 sites in Belgium
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Subjects With Impaired Renal Function and Healthy Subjects
A Study to Evaluate the Pharmacokinetics of Apatinib in Subjects With Impaired Renal Function
The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects with impaired renal function and healthy subjects, to give dose recommendations for patients with impaired renal function.
- Trial name
- NCT04414852
- Testing
- Apatinib Mesylate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Impaired Renal Function
Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.
- Trial name
- NCT04179630
- Testing
- Aldafermin (NGM282)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
Normal Renal Function, Impaired Renal Function
A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function
For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.
- Trial name
- NCT02965040
- Testing
- Roxadustat
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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.
Iron Deficiency Anemia, Impaired Renal Function
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron…
- Trial name
- REPAIR-IDA (NCT00981045)
- Testing
- Ferric Carboxymaltose (FCM), Iron Sucrose (Venofer)
- Where
- United States
- Volunteers
- 2,561 people
- Sponsor
- American Regent, Inc.
Patients With Impaired Renal Function and Haemodialysis
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
- Trial name
- NCT02629224
- Testing
- ASP8825
- Where
- 2 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Astellas Pharma Inc
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.
Normal Renal Function, Mildly Impaired Renal Function
Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).
- Conditions
- Normal Renal Function, Mildly Impaired Renal Function, Moderately Impaired Renal Function
- Trial name
- NCT00543075
- Testing
- Genasense (oblimersen, G3139)
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Genta Incorporated