Clinical trials: Kidney Insufficiency
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
Chronic Kidney Disease
Effect of Low Frequency Ultrasound on Kidney Function
The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.
- Trial name
- NCT02026544
- Testing
- Low Frequency Therapeutic Ultrasound
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sonogenix
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
Anemia Associated With Chronic Kidney Disease
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who…
- Trial name
- NCT04621331
- Testing
- Roxadustat
- Where
- 4 sites in United States
- Sponsor
- Kyntra Bio
Gastrointestinal Cancer
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured…
- Trial name
- FOLFOX4 (NCT00094965)
- Testing
- Oxaliplatin (SR96669)
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Sanofi
Chronic Kidney Disease, Chronic Renal Failure
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated…
- Trial name
- AiME - 01 (NCT01473407)
- Testing
- Epoetin Hospira, Epogen (Amgen)
- Where
- 85 sites in United States, Puerto Rico
- Volunteers
- 612 people
- Sponsor
- Pfizer
Hepatitis C, Chronic
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and…
- Trial name
- NCT02864199
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 63 people
- Sponsor
- Hoffmann-La Roche
End-stage Renal Disease
Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease
The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other…
- Trial name
- NCT04395131
- Testing
- Clearum HF Hemodialyzer
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Mozarc Medical US LLC
HCV Infection
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state…
- Trial name
- NCT01958281
- Testing
- SOF, RBV, LDV/SOF
- Where
- 10 sites in United States, New Zealand and 1 more
- Volunteers
- 38 people
- Sponsor
- Gilead Sciences
Kidney Disease, Chronic, End Stage Kidney Disease
An Observational Study of Patients With Chronic Kidney Disease
TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).
- Trial name
- NCT05774392
- Testing
- Observational
- Sponsor
- Target PharmaSolutions, Inc.
Renal Failure
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.
- Trial name
- NCT00240331
- Testing
- 10mg Rosuvastatin
- Where
- 239 sites in Australia, Austria and 23 more
- Volunteers
- 2,776 people
- Sponsor
- AstraZeneca
Chronic Kidney Diseases
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients.
- Trial name
- NCT03708562
- Testing
- everlinQ endoAVF System
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- C. R. Bard
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Kidney Failure, Chronic
Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood
The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.
- Trial name
- NCT00150566
- Testing
- Lanthanum carbonate
- Volunteers
- 460 people
- Sponsor
- Shire
Relapsed/Refractory Solid Tumors/Hematological Malignancies
To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment.
- Trial name
- NCT02679131
- Testing
- Belinostat
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Acrotech Biopharma Inc.
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
- Trial name
- IN-REALITY (NCT06763146)
- Testing
- Finerenone (Kerendia, BAY948862)
- Where
- India
- Volunteers
- 1,200 people
- Sponsor
- Bayer
Severe Renal Impairment
A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine
The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function.
- Trial name
- NCT01675973
- Testing
- RANEXA
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy, Renal Dysfunction
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan…
- Trial name
- NCT04935294
- Testing
- Danicopan
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Kidney Failure, Graft vs Host Disease
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
The incidence of efficacy failure at 12 months between two regimens.
- Conditions
- Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation
- Trial name
- NCT00044720
- Testing
- Rapamune
- Volunteers
- 484 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Anemia, Mortality
Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced…
- Trial name
- NCT01017627
- Testing
- Early anemia diagnosis and treatment, No change from normal routine
- Where
- 42 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Fresenius Medical Care North America
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