Clinical trials: Renal Dysfunction
Parkinson Disease
Special Survey on PD Patients With Renal Dysfunction
The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings in Japan.
- Trial name
- NCT00613756
- Where
- 98 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Boehringer Ingelheim
Hemodialysis, Healthy
Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the…
- Trial name
- NCT03947970
- Testing
- [14C] CR845
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cara Therapeutics, Inc.
Kidney Failure, Chronic Therapy; Hemodialysis
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
- Trial name
- NCT01920854
- Testing
- soluble ferric pyrophosphate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Rockwell Medical Technologies, Inc.
Antibiotic Toxicity
A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency
This is an open-label, single-center, single-dose, parallel-group study to evaluate the PK and safety profiles of polymyxin B administered by IV infusion in healthy subjects and subjects with renal insufficiency.
- Trial name
- NCT05359627
- Testing
- Polymyxin B
- Where
- Taiwan
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- TTY Biopharm
Chronic Kidney Failure, Secondary Hyperparathyroidism
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
- Trial name
- PROTECT (NCT01083186)
- Where
- 24 sites in Greece
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease, Hyperphosphatemia
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis
Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries.
- Trial name
- ASPIRE (NCT00833768)
- Testing
- Sevelamer carbonate
- Where
- 36 sites in Austria, France and 7 more
- Volunteers
- 5 people
- Sponsor
- Genzyme, a Sanofi Company
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
Renal Impairment
A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
to quantify the effect of different degrees of renal impairment on the pharmacokinetics of BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal…
- Trial name
- NCT01904214
- Testing
- BAF312
- Where
- 2 sites in United States, Romania
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C
Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)
The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of MK-3682B, a fixed dose combination (FDC) tablet containing uprifosbuvir (MK-3682) + grazoprevir (MK-5172) + ruzasvir (MK-8408) in…
- Trial name
- NCT02661126
- Testing
- MK-3682B
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Amyotrophic Lateral Sclerosis, Renal Insufficiency
Dexpramipexole Renal PK Study
This is a multicenter, open-label, single-dose, PK and safety study in subjects with various stages of renal impairment.
- Trial name
- NCT01424176
- Testing
- Dexpramipexole (dose 1), Dexpramipexole (dose 2)
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Knopp Biosciences
Staphylococcal Infections, Chronic Kidney Failure
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a…
- Trial name
- SHIELD-2 (NCT00130260)
- Testing
- Staph aureus types 5 and 8 conjugate vaccine
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Nabi Biopharmaceuticals
Renal Impairment
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.
- Trial name
- NCT01028768
- Testing
- Teduglutide
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- Nycomed
Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
- Trial name
- NCT00837824
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company
Acute Kidney Injury
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
The objective of this sample collection study is to collect blood and urine samples. This study is observational and will have no impact on the medical management of the subject.
- Trial name
- NCT01573962
- Where
- 23 sites in United States
- Volunteers
- 420 people
- Sponsor
- Astute Medical, Inc.
End Stage Renal Disease
Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
In China, the estimated prevalence of patients with ESRD receiving PD or maintenance HD increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008.
- Trial name
- NCT03547336
- Testing
- Theranova 400 Dialyzer, FX800 Dialyzer
- Where
- 8 sites in China
- Volunteers
- 212 people
- Sponsor
- Vantive Health LLC
Kidney Failure, Chronic
Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease
The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's…
- Trial name
- NCT00160121
- Testing
- Lanthanum carbonate
- Volunteers
- 2,500 people
- Sponsor
- Shire
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients…
- Trial name
- AiME - 03 (NCT01628107)
- Testing
- Epoetin Hospira
- Where
- 110 sites in United States, Puerto Rico
- Volunteers
- 406 people
- Sponsor
- Pfizer
Infection, Human Immunodeficiency Virus
Dolutegravir Renal Impairment Study
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV Healthcare LLC.
- Trial name
- NCT01353716
- Testing
- Dolutegravir 50 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Renal Insufficiency, Acute, Renal Insufficiency, Chronic
Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency
This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.
- Conditions
- Renal Insufficiency, Acute, Renal Insufficiency, Chronic, Healthy Subjects
- Trial name
- NCT02808052
- Testing
- Minocin (minocycline) for Injection
- Where
- Germany
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Chronic Kidney Diseases
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney…
- Trial name
- NCT06071143
- Testing
- KDSTEM Inj.
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- EHL Bio Co., Ltd.
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