Clinical trials: Pre-ESRD
Anemia, Renal Diseases
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney…
- Trial name
- NCT00440466
- Testing
- epoetin alfa
- Where
- 66 sites in United States
- Volunteers
- 430 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Anemia, Kidney Failure
Dynepo Infrequent Dosing Study
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and…
- Trial name
- NCT00450333
- Testing
- Dynepo (Epoetin delta), Dynepo
- Where
- 53 sites in Austria, Belgium and 5 more
- Volunteers
- 407 people
- Sponsor
- Shire
Cardiovascular Diseases, Kidney Failure, Chronic
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
- Trial name
- NCT01241539
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
End Stage Renal Disease
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.
- Trial name
- NCT04198012
- Testing
- HemoCare™ Hemodialysis System
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Deka Research and Development
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
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
Anemia, Kidney Failure
A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.
The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.
- Conditions
- Anemia, Kidney Failure, Left Ventricular Hypertrophy
- Trial name
- NCT00364260
- Testing
- epoetin alfa
- Volunteers
- 172 people
- Sponsor
- Janssen-Ortho Inc., Canada
Kidney Disease
Aranesp® Monthly Preference Study - 2
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
- NCT00117078
- Testing
- Aranesp®
- Sponsor
- Amgen
Chronic Kidney Disease
Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
- Trial name
- NCT02805348
- Testing
- Bixalomer
- Where
- 14 sites in Japan
- Volunteers
- 144 people
- Sponsor
- Astellas Pharma Inc
Chronic Renal Failure
Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased.
- Trial name
- NCT02378194
- Testing
- HD-003 (800mg/day), HD-003 (1600mg/day)
- Volunteers
- 62 people
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Pre-dialysis, End Stage Renal Disease
NESP Pediatric Study
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period.
- Trial name
- NCT00527137
- Testing
- darbepoetin alfa, rHuEPO
- Volunteers
- 120 people
- Sponsor
- Amgen
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.
Preeclampsia, Hypertension
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia
- Trial name
- NCT02780414
- Where
- 20 sites in United States
- Volunteers
- 1,730 people
- Sponsor
- Progenity, Inc.
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
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
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.
Renal Insufficiency, Diabetes Mellitus
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at…
- Trial name
- NCT00209417
- Testing
- Iodixanol 320-Arm 1, Iopamidol 300-Arm 2
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 656 people
- Sponsor
- GE Healthcare
Anemia, Chronic Renal Insufficiency
Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.
- Trial name
- SWEEP (NCT00869856)
- Testing
- HX575 solution for s.c. administration
- Where
- 19 sites in Bulgaria, France and 3 more
- Sponsor
- Sandoz
Chronic Kidney Disease, Chronic Renal Insufficiency
STAAR-3 Clinical Study
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.
- Conditions
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis
- Trial name
- NCT00369733
- Testing
- Darbepoetin alfa
- Volunteers
- 443 people
- Sponsor
- Amgen
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