Clinical trials: Pre-ESRD
Chronic Kidney Disease
Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet
The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal…
- Trial name
- NCT02649205
- Testing
- Observational study: Supplemented protein-restricted diet
- Where
- Hungary
- Volunteers
- 164 people
- Sponsor
- Fresenius Kabi
Kidney Transplantation, Transplantation
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation.
- Trial name
- NCT00297310
- Testing
- tacrolimus
- Volunteers
- 89 people
- Sponsor
- Janssen-Cilag Pty Ltd
Kidney Transplant, Kidney Failure
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors.
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Trial name
- NEWHOPE (NCT07792317)
- Testing
- Omnisol organ preservation solution
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Vivalyx GmbH
End Stage Renal Failure on Dialysis
Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
The purpose of the investigation is to confirm the safety and performance of the Argyle™ Safety Fistula Cannula with Anti-reflux Valve for hemodialysis treatment.
- Trial name
- NCT05927532
- Testing
- Argyle Safety Fistula Cannula with Anti-Reflux Valve
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Mozarc Medical US LLC
Anemia, Chronic Kidney Disease
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.
- Trial name
- NCT01906489
- Testing
- AKB-6548
- Where
- 47 sites in United States
- Volunteers
- 210 people
- Sponsor
- Akebia Therapeutics
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
Chronic Kidney Disease, Chronic Renal Insufficiency
STAAR-1 Clinical Study
To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy
- Conditions
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis
- Trial name
- NCT00369772
- Testing
- darbepoetin alfa
- Volunteers
- 2,000 people
- Sponsor
- Amgen
Anemia
Treatment of Anemia in Diabetic Subjects With CKD
The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRIT®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline…
- Trial name
- NCT00240734
- Testing
- Epoetin alfa
- Volunteers
- 11 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Kidney Disease
Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia
The purpose of this study is to characterize the safety and efficacy of repeat doses of compound 1278863A in subjects with anemia.
- Trial name
- NCT01047397
- Testing
- 1278863A
- Where
- 37 sites in Australia, India and 2 more
- Volunteers
- 107 people
- Sponsor
- GlaxoSmithKline
Kidney Disease
Study to Evaluate Effectiveness of Aranesp®
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).
- Trial name
- NCT00117130
- Testing
- Aranesp®
- Sponsor
- Amgen
Chronic Kidney Disease
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
- Trial name
- SENSE (NCT01576341)
- Testing
- HX575 epoetin alfa (Sandoz)
- Where
- 50 sites in Germany, Italy and 5 more
- Volunteers
- 417 people
- Sponsor
- Sandoz
Anemia of Chronic Kidney Disease
To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)
This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients.
- Trial name
- NCT03521713
- Testing
- EPORON, EPREX
- Where
- Turkey (Türkiye)
- Volunteers
- 214 people
- Sponsor
- Dong-A ST Co., Ltd.
Chronic Kidney Disease, Renal Insufficiency
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.
- Trial name
- NCT00908310
- Testing
- Omniscan
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- GE Healthcare
End-Stage Renal Disease Requiring Haemodialysis
Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation.
- Trial name
- Amplifi FIH (NCT07058610)
- Testing
- Amplifi Vein Dilation System
- Where
- Paraguay
- Volunteers
- 19 people
- Sponsor
- Amplifi Vascular, Inc.
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
Kidney Transplantation in Highly Sensitized Patients
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
- Trial name
- DINKY (NCT05753930)
- Testing
- Imlifidase
- Where
- 6 sites in Finland, France and 3 more
- Volunteers
- 10 people
- Sponsor
- Hansa Biopharma AB
Kidney Disease, Chronic
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice.
- Trial name
- NCT02547454
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 12 sites in Slovenia
- Volunteers
- 393 people
- Sponsor
- Hoffmann-La Roche
Anemia, Chronic Kidney Disease
Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease
To evaluate the safety profile of single intravenous (IV) dose levels of peginesatide in participants with chronic kidney disease(CKD) not on dialysis.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00109291
- Testing
- peginesatide
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Affymax
Anemia, Renal Insufficiency, Chronic
Long-term Pre-dialysis Extension in Europe and Asia Pacific
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood.
- Trial name
- DIALOGUE 3 (NCT02055482)
- Testing
- Molidustat (BAY85-3934), Darbepoetin
- Where
- 105 sites in Australia, Bulgaria and 12 more
- Volunteers
- 166 people
- Sponsor
- Bayer
Diabetes Mellitus, Type 2, Renal Insufficiency
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
- Trial name
- NCT01164501
- Testing
- BI 10773
- Where
- 127 sites in United States, Canada and 13 more
- Volunteers
- 741 people
- Sponsor
- Boehringer Ingelheim