Clinical trials: Predialysis
Anemia
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA.
- Trial name
- NCT00680563
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 22 sites in Argentina, Brazil and 8 more
- Volunteers
- 4 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
Anemia, Kidney Disease, Chronic
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis
This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis…
- Trial name
- NCT01309295
- Where
- Albania
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B Virus Infection
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
- Trial name
- NCT00440297
- Testing
- Comparator: modified process hepatitis B vaccine, Comparator: ENGERIX-B™
- Volunteers
- 277 people
- Sponsor
- Merck Sharp & Dohme LLC
Anemia in Pre-Dialysis Patients
Clinical Study of R744 to Predialysis Patients
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
- Trial name
- NCT00433615
- Testing
- R744
- Where
- 6 sites in Japan
- Volunteers
- 124 people
- Sponsor
- Chugai Pharmaceutical
Chronic Renal Failure
EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.
- Trial name
- NCT00338000
- Testing
- Epoetin alfa
- Volunteers
- 292 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
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 Failure, Secondary Hyperparathyroidism
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
- Trial name
- PROTECT (NCT01083186)
- Where
- 24 sites in Greece
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hypertension
VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild…
- Trial name
- NCT00171080
- Testing
- valsartan, irbesartan
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 86 people
- Sponsor
- Novartis
Anemia
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia.
- Trial name
- NCT02569515
- Testing
- Epoetin Beta
- Where
- 4 sites in Bulgaria
- Volunteers
- 58 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
Predialysis Patients
Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)
This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.
- Trial name
- NCT00492427
- Testing
- R744, Epoetin beta
- Where
- 6 sites in Japan
- Volunteers
- 187 people
- Sponsor
- Chugai Pharmaceutical
Anemia, Chronic Renal Insufficiency
Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia. Symptomatic anemia will be corrected by s.c.
- Trial name
- NCT00701714
- Testing
- HX575 recombinant human erythropoietin alfa, ERYPO
- Where
- 123 sites in Austria, Bulgaria and 8 more
- Volunteers
- 337 people
- Sponsor
- Sandoz
Anemia
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta).
- Trial name
- NCT01356589
- Where
- 33 sites in Greece
- Volunteers
- 1,288 people
- Sponsor
- Hoffmann-La Roche
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