Clinical trials: Pre-dialysis
Arteriovenous Fistula Stenosis
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous…
- Trial name
- NCT05034939
- Testing
- FLEX Vessel Prep System, Angioplasty
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- VentureMed Group Inc.
Anemia
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who…
- Trial name
- NCT00661388
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 9 sites in Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Hoffmann-La Roche
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
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
Anemia
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating…
- Trial name
- NCT00462384
- Testing
- Methoxy Polyethylene Glycol-epoetin Beta
- Where
- 22 sites in Estonia, Finland and 2 more
- Volunteers
- 39 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
Hyperkalemia
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
- Trial name
- DIALIZE (NCT03303521)
- Testing
- Sodium Zirconium Cyclosilicate (ZS)
- Where
- 53 sites in United States, Japan and 2 more
- Volunteers
- 196 people
- Sponsor
- AstraZeneca
Anemia
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic…
- Trial name
- ORION (NCT00773968)
- Testing
- Methoxy Polyethylene Glycol-Epoetin Beta
- Where
- 34 sites in Italy
- Volunteers
- 140 people
- Sponsor
- Hoffmann-La Roche
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
Anemia, Kidney Disease, Chronic
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12…
- Trial name
- ALTITUD (NCT01519947)
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 7 sites in Mexico
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
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
Hyperkalemia
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic…
- Trial name
- DIALIZE China (NCT04217590)
- Testing
- Sodium Zirconium Cyclosilicate
- Where
- 36 sites in China
- Volunteers
- 134 people
- Sponsor
- AstraZeneca
Anemia
A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and…
- Trial name
- NCT00576628
- Testing
- methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
- Where
- 19 sites in Russia
- Volunteers
- 133 people
- Sponsor
- Hoffmann-La Roche
Anemia
Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal…
- Trial name
- NCT00517881
- Testing
- Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
- Where
- 14 sites in Sweden
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on…
- Trial name
- NCT01342640
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 5 sites in Egypt
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
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