Clinical trials: Renal Anemia
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 Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia.
- Trial name
- NCT00737464
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 17 sites in India
- Volunteers
- 132 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin.
- Trial name
- NCT00077623
- Testing
- epoetin alfa or beta, methoxy polyethylene glycol-epoetin beta (Mircera)
- Where
- 90 sites in United States, Belgium and 19 more
- Volunteers
- 572 people
- Sponsor
- Hoffmann-La Roche
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients…
- Trial name
- AiME - 13 (NCT01473420)
- Testing
- Epoetin Hospira, Epogen Amgen
- Where
- 73 sites in United States
- Volunteers
- 320 people
- Sponsor
- Pfizer
Anemia
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin.
- Trial name
- NCT00077610
- Testing
- Epoetin alfa or beta, RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks)
- Where
- 99 sites in United States, Canada and 6 more
- Volunteers
- 673 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia.
- Trial name
- NCT00882713
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 12 sites in Morocco
- Volunteers
- 202 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin…
- Trial name
- NCT00454246
- Testing
- methoxy polyethylene glycol-epoetin beta, epoetin alfa, darbepoetin alfa
- Where
- 78 sites in United States
- Volunteers
- 111 people
- Sponsor
- Hoffmann-La Roche
Renal Insufficiency, Chronic, Anemia
Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving…
- Conditions
- Renal Insufficiency, Chronic, Anemia, Renal Dialysis, Erythrocyte Transfusion
- Trial name
- NCT02253654
- Testing
- Epoetin alfa
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 216 people
- Sponsor
- Amgen
Chronic Kidney Disease, End Stage Renal Disease
TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.
- Trial name
- NCT02117427
- Testing
- MDGN201 TARGTEPO
- Where
- 5 sites in Israel
- Volunteers
- 11 people
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
Anemia
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia.
- Trial name
- OPTIMA (NCT01902628)
- Where
- 24 sites in Greece
- Volunteers
- 437 people
- Sponsor
- Hoffmann-La Roche
Anemia
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease…
- Trial name
- NCT00317239
- Testing
- Ferrous Sulfate tablets, Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- American Regent, 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
Anemia
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia.
- Trial name
- NCT00545571
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 27 sites in Austria, Switzerland
- Volunteers
- 120 people
- Sponsor
- Hoffmann-La Roche
Anaemia
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive…
- Trial name
- NCT01977573
- Testing
- GSK1278863, rhEPO
- Where
- 123 sites in United States, Australia and 13 more
- Volunteers
- 252 people
- Sponsor
- GlaxoSmithKline
Anemia
A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
- Trial name
- NCT01146574
- Testing
- Sotatercept
- Where
- 24 sites in United States
- Volunteers
- 50 people
- Sponsor
- Celgene
Anemia, Kidney Diseases
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to…
- Conditions
- Anemia, Kidney Diseases, Renal Failure, Chronic, Kidney Failure, Chronic
- Trial name
- DELFT (NCT00664066)
- Testing
- DYNEPO (epoetin delta)
- Where
- 2 sites in Germany
- Volunteers
- 3 people
- Sponsor
- Shire
Anaemia
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated…
- Trial name
- ASCEND-P (NCT05682326)
- Testing
- Daprodustat
- Where
- 4 sites in Japan, South Korea
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Peritoneal Dialysis (PD), Anemia
Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in patients with chronic kidney…
- Conditions
- Peritoneal Dialysis (PD), Anemia, Chronic Kidney Disease
- Trial name
- NCT02909153
- Testing
- Triferic
- Volunteers
- 30 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Anemia of Chronic Kidney Disease
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients…
- Trial name
- NCT04655027
- Testing
- Roxadustat, rHuEPO
- Where
- 8 sites in China
- Volunteers
- 25 people
- Sponsor
- AstraZeneca
End-Stage Renal Disease
Intelligent Control Approach to Anemia Management
First clinical evaluation of "Smart Anemia Manager" algorithm.
- Trial name
- NCT00572533
- Testing
- ESA Dose Adjustment per standard Anemia Management Protocol, ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Louisville