Clinical trials: Pre-Dialysis
Hepatitis B
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™.
- Trial name
- NCT00445185
- Testing
- Henogen HB vaccine, Fendrix vaccine
- Where
- 23 sites in Belgium, Czechia and 1 more
- Volunteers
- 102 people
- Sponsor
- Henogen
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
Atypical Hemolytic Uremic Syndrome
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.
- Trial name
- NCT05795140
- Testing
- Iptcaopan 200 mg
- Where
- 9 sites in Brazil, China and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
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, Chronic Renal Insufficiency
STAAR-2 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
- NCT00368901
- Testing
- Darbepoetin alfa
- Volunteers
- 618 people
- Sponsor
- Amgen
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
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
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
Anemia in Pre-Dialysis Patients
Phase II Dose-Finding of Oral SSS17 for Anemia in Non-Dialysis CKD
This study primarily evaluates the efficacy and safety of oral SSS17 capsules in treating anemia in patients with non-dialysis chronic kidney disease, as well as the pharmacokinetic and pharmacodynamic (PK/PD) characteristics of…
- Trial name
- NCT07014631
- Testing
- SSS17
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Pre-Dialysis
Fixed Dose NESP Study in Subjects With CRI
Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be…
- Trial name
- NCT00526929
- Testing
- darbepoetin alfa
- Volunteers
- 75 people
- Sponsor
- Amgen
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
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
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
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.
Pre-Dialysis
Phase 2 Study of Darbepoetin Alfa Extended Dosing
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks.
- Trial name
- NCT00527215
- Testing
- darbepoetin alfa
- Volunteers
- 98 people
- Sponsor
- Amgen
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
Renal Insufficiency, Chronic
Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients
Supplementation of ketoanalogues of essential amino acids improves the protein quality of protein restricted diets without burdening the kidneys.
- Trial name
- CKD (NCT03077048)
- Testing
- Ketosteril®
- Where
- Czechia
- Volunteers
- 23 people
- Sponsor
- Fresenius Kabi
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
Hepatitis B
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced.
- Trial name
- NCT00291980
- Testing
- HB-AS02V vaccine, HBVAXPRO vaccine
- Where
- 28 sites in Belgium, Czechia and 1 more
- Volunteers
- 185 people
- Sponsor
- Henogen
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