Clinical trials: Renal Dysfunction
Pharmacokinetics
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal…
- Trial name
- NCT01084278
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Renal Insufficiency, Healthy
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged 18 years and older. People without kidney problems and people who have moderate or severe kidney problems can join the study.
- Trial name
- NCT05718648
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cardiac Surgery
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute…
- Trial name
- NCT04654221
- Testing
- mGFR by iohexol clearance
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Quark Pharmaceuticals
Fibromyalgia
Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease
DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia (FM) pain. Because it is excreted through the kidneys, people who have reduced kidney function will not process the drug as well as with those with normal…
- Trial name
- NCT02496884
- Testing
- DS-5565
- Where
- 39 sites in United States, Bulgaria and 6 more
- Volunteers
- 56 people
- Sponsor
- Daiichi Sankyo
Kidney Failure, Chronic, End-Stage Kidney Disease
A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)
The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time.
- Conditions
- Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic, Renal Failure, End-Stage
- Trial name
- NCT06814132
- Testing
- MK-5684, Prednisone, Fludrocortisone acetate
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hyperphosphatemia, Kidney Failure
EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)
The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.
- Trial name
- NCT00211978
- Testing
- calcium acetate
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Nabi Biopharmaceuticals
Diabetic Nephropathy, Chronic Kidney Disease
The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors
The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and…
- Trial name
- VITAL (NCT00421733)
- Testing
- Zemplar (paricalcitol ) capsules, Zemplar (paricalcitol) capsules
- Where
- 72 sites in United States, Germany and 8 more
- Volunteers
- 281 people
- Sponsor
- Abbott
Chronic Kidney Disease
EPO Deep Tank in Dialysis Subjects
Subject incidence of adverse events
- Trial name
- NCT00156949
- Testing
- Epoetin alfa DT
- Volunteers
- 580 people
- Sponsor
- Amgen
Infections, Bacterial
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required.
- Trial name
- NCT02729038
- Testing
- Gepotidacin
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
End Stage Renal Disease (ESRD)
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.
- Trial name
- NCT02604264
- Testing
- ClearGuard HD end cap
- Where
- United States
- Volunteers
- 2,912 people
- Sponsor
- Pursuit Vascular, Inc.
Mild and Moderate Renal Impairment
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.
- Trial name
- NCT01569815
- Testing
- LCZ696
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Secondary Hyperparathyroidism
ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism
The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National…
- Trial name
- NCT00135304
- Testing
- Sensipar®, Vitamin D
- Volunteers
- 170 people
- Sponsor
- Amgen
Chronic Kidney Disease
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.
- Trial name
- NCT02620306
- Testing
- Fimsartan 60mg~120mg, Losartan 50mg~100mg
- Where
- South Korea
- Volunteers
- 351 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Renal Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.
- Trial name
- NCT03289208
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Insufficiency
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.
- Trial name
- NCT01432535
- Testing
- PegIFN-2b (Sylatron®)
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Type 2 DM Patients With Moderate or Severe Renal Impairment
A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or…
- Trial name
- GUARD (NCT01968044)
- Testing
- Gemigliptin
- Where
- South Korea
- Volunteers
- 132 people
- Sponsor
- LG Life Sciences
Anemia
Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were…
- Trial name
- NCT00752609
- Testing
- Peginesatide
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Takeda
End Stage Renal Disease, End Stage Renal Disease on Dialysis
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center…
- Conditions
- End Stage Renal Disease, End Stage Renal Disease on Dialysis, End Stage Kidney Disease
- Trial name
- NCT06581393
- Testing
- Moda-flx Hemodialysis System
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Diality Inc.
HIV Infections, Fanconi Syndrome
Fanconi Syndrome Due to ARVs in HIV-Infected Persons
Cross-sectional cohort study of participants with HIV with or without protocol-defined Fanconi syndrome (confirmed creatinine clearance [CLcr] decline and evidence of proximal tubulopathy).
- Conditions
- HIV Infections, Fanconi Syndrome, Kidney Disease, Renal Impairment
- Trial name
- NCT00499187
- Testing
- Blood Draws
- Where
- 13 sites in United States, Canada
- Volunteers
- 56 people
- Sponsor
- Gilead Sciences
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