Clinical trials: Renal Insufficiency
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Impairment, End-stage Renal Disease
An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
- Trial name
- NCT02397395
- Testing
- Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg
- Where
- 6 sites in France, Spain
- Sponsor
- Janssen R&D Ireland
Elective Cardiac Surgery
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
- Trial name
- REFRESH II-AKI (NCT03384875)
- Testing
- CytoSorb
- Where
- 20 sites in United States
- Volunteers
- 186 people
- Sponsor
- CytoSorbents, Inc
Coronary Artery Bypass Surgery, Coronary Heart Disease
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00653042
- Testing
- Nesiritide
- Volunteers
- 305 people
- Sponsor
- Scios, Inc.
Anemia
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease…
- Trial name
- NCT00317239
- Testing
- Ferrous Sulfate tablets, Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- American Regent, Inc.
Chronic Kidney Disease, Hyperlipidemia
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
Study design Multicenter, double-dummy, double-blinded, randomized, Phase 4 study Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs Study…
- Trial name
- HM-SIM4 (NCT01564875)
- Testing
- Simvast CR, Zocor
- Where
- 7 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Renal Impairment
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.
- Trial name
- NCT01578928
- Testing
- SOM230
- Where
- 2 sites in Germany, South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Insufficiency
A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.
- Trial name
- NCT03545087
- Testing
- Lanabecestat, Iohexol
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hypertension, Vascular Diseases
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SWYFT (NCT07115953)
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Vascular
Graft Rejection, Kidney Failure
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00273871
- Testing
- Cyclosporin or tacrolimus
- Volunteers
- 190 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Chronic Kidney Disease, Anemia
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
- Trial name
- NCT01244763
- Testing
- Roxadustat
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Kyntra Bio
Heart Failure, Renal Insufficiency
Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment
CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to…
- Trial name
- NCT02603614
- Testing
- Cenderitide
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Capricor Inc.
Diabetes Mellitus, Type 2
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose…
- Trial name
- NCT01581658
- Testing
- BI10773
- Where
- Japan
- Volunteers
- 32 people
- Sponsor
- Boehringer Ingelheim
Anemia, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is…
- Conditions
- Anemia, Chronic Kidney Disease, Kidney Disease
- Trial name
- NCT00436748
- Testing
- Darbepoetin Alfa
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 116 people
- Sponsor
- Amgen
Renal Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
- Trial name
- NCT03443063
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Impairment
Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment
This is a single dose, non-randomized, open-label, parallel group study. The study will be conducted in participants with severe renal impairment and compared with matched participants with normal renal function.
- Trial name
- NCT04469907
- Testing
- AZD9977
- Where
- 6 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
- Conditions
- Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT), Hemodialysis (HD)
- Trial name
- 2007 (NCT01453634)
- Testing
- Lunacalcipol 180, Lunicalcipol 270
- Sponsor
- OPKO Health, Inc.
End-Stage Kidney Disease
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to…
- Trial name
- NCT00062699
- Testing
- Zemplar (paricalcitol injection), Calcijex
- Where
- 60 sites in United States
- Volunteers
- 2,200 people
- Sponsor
- Abbott
Soft Tissue Infections
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the…
- Trial name
- NCT00102947
- Testing
- daptomycin (up to 14 days)
- Where
- 12 sites in United States
- Volunteers
- 72 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
- Trial name
- NCT01439867
- Testing
- Cinacalcet hydrochloride, Standard of Care
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 18 people
- Sponsor
- Amgen
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