Clinical trials: Pre-ESRD
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 of Chronic Kidney Disease
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled…
- Trial name
- NCT04036253
- Testing
- Erythropoietin alfa
- Where
- 11 sites in Argentina, Paraguay
- Volunteers
- 43 people
- Sponsor
- Bio Sidus SA
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
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 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
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
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
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
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
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
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