Clinical trials: Pre-Dialysis
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, Renal Insufficiency, Chronic
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood.
- Trial name
- DIALOGUE 1 (NCT02021370)
- Testing
- BAY85-3934
- Where
- 56 sites in Australia, Bulgaria and 12 more
- Volunteers
- 121 people
- Sponsor
- Bayer
Anemia
A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who…
- Trial name
- NCT00081484
- Testing
- epoetin alfa or beta, methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 66 sites in United States, Canada and 10 more
- Volunteers
- 336 people
- Sponsor
- Hoffmann-La Roche
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
Anemia, Renal Insufficiency, Chronic
Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood.
- Trial name
- DIALOGUE 2 (NCT02021409)
- Testing
- BAY85-3934, Darbepoetin alfa
- Where
- 51 sites in Australia, Bulgaria and 12 more
- Volunteers
- 126 people
- Sponsor
- Bayer
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 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
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
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
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
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, Chronic Renal Insufficiency
STAAR-1 Clinical Study
To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy
- Conditions
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis
- Trial name
- NCT00369772
- Testing
- darbepoetin alfa
- Volunteers
- 2,000 people
- Sponsor
- Amgen
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, Renal Insufficiency, Chronic
Long-term Pre-dialysis Extension in Europe and Asia Pacific
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood.
- Trial name
- DIALOGUE 3 (NCT02055482)
- Testing
- Molidustat (BAY85-3934), Darbepoetin
- Where
- 105 sites in Australia, Bulgaria and 12 more
- Volunteers
- 166 people
- Sponsor
- Bayer
Hepatitis B
Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
- Trial name
- NCT00291954
- Testing
- HB-AS02V, HBVAXPRO vaccine
- Where
- 25 sites in Belgium, Czechia and 1 more
- Volunteers
- 257 people
- Sponsor
- Henogen
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
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
Anemia, Kidney Diseases
Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.
The purpose of this study is to evaluate the hemoglobin response rate in subjects with anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRIT®) every 2 weeks
- Trial name
- NCT00210743
- Testing
- epoetin alfa
- Volunteers
- 67 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
Anemia
Treatment of Anemia in Diabetic Subjects With CKD
The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRIT®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline…
- Trial name
- NCT00240734
- Testing
- Epoetin alfa
- Volunteers
- 11 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.