Clinical trials: Anemia Associated Chronic Kidney Disease
Anaemia
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
- Trial name
- NCT02876835
- Testing
- Daprodustat, Darbepoetin alfa, Iron Therapy
- Where
- 574 sites in United States, Argentina and 37 more
- Volunteers
- 3,872 people
- Sponsor
- GlaxoSmithKline
Anemia, Renal Insufficiency, Chronic
Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels.
- Trial name
- DIALOGUE4 (NCT01975818)
- Testing
- Molidustat (BAY 85-3934), Epoetin alfa/beta
- Where
- 35 sites in United States, Japan
- Volunteers
- 201 people
- Sponsor
- Bayer
Anaemia
4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable rhEPO to GSK1278863 in approximately 68…
- Trial name
- NCT01587924
- Testing
- GSK1278863, rhEPO
- Where
- 62 sites in United States, Canada and 4 more
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
Anemia Associated With Chronic Kidney Disease (CKD)
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of…
- Trial name
- NCT04707768
- Testing
- Vadadustat, Mircera®
- Where
- 58 sites in United States
- Volunteers
- 456 people
- Sponsor
- Akebia Therapeutics
Anaemia, Aspergillosis, Allergic Bronchopulmonary
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
- Trial name
- NCT02879305
- Testing
- Daprodustat, rhEPO, Iron therapy
- Where
- 462 sites in United States, Argentina and 33 more
- Volunteers
- 2,964 people
- Sponsor
- GlaxoSmithKline
Anaemia
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese…
- Trial name
- NCT02969655
- Testing
- Daprodustat small, Daprodustat large, Darbepoetin alfa
- Where
- 50 sites in Japan
- Volunteers
- 271 people
- Sponsor
- GlaxoSmithKline
Anaemia Associated With Chronic Kidney Disease
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient
This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for…
- Trial name
- NCT04155125
- Testing
- efepoetin alfa, Mircera
- Where
- 55 sites in Australia, Indonesia and 5 more
- Volunteers
- 391 people
- Sponsor
- PT Kalbe Genexine Biologics
Anaemia
Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50…
- Trial name
- NCT02791763
- Testing
- 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet, Epoetin beta pegol
- Where
- 56 sites in Japan
- Volunteers
- 355 people
- Sponsor
- GlaxoSmithKline
Anaemia
Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents
This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia not using erythropoiesis-stimulating agents…
- Trial name
- NCT02829320
- Testing
- GSK1278863, Iron
- Where
- 17 sites in Japan
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
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, Renal Insufficiency, Chronic
Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose.
- Trial name
- DIALOGUE5 (NCT02064426)
- Testing
- Molidustat (BAY85-3934), Epoetin alfa/beta
- Where
- 26 sites in United States, Japan
- Volunteers
- 88 people
- Sponsor
- Bayer
Anemia, Chronic Kidney Disease
A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating…
- Trial name
- NCT00924781
- Testing
- MK2578 1mcg for every 600 Units (U) of Epogen® (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 350 U of Epogen (epoetin alfa) received per week at Baseline, MK2578 1 mcg for every 200 U of Epogen (epoetin alfa) received per week at Baseline
- Volunteers
- 39 people
- Sponsor
- Merck Sharp & Dohme LLC
Anaemia
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
- Trial name
- NCT03029208
- Testing
- Daprodustat, Darbepoetin alfa, Iron therapy
- Where
- 111 sites in United States, Argentina and 13 more
- Volunteers
- 312 people
- Sponsor
- GlaxoSmithKline
Anemia Associated Chronic Kidney Disease
Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.
- Trial name
- NCT04470063
- Testing
- DDO-3055 tablets
- Where
- 12 sites in China
- Volunteers
- 30 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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 Associated With Chronic Kidney Disease
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who…
- Trial name
- NCT04621331
- Testing
- Roxadustat
- Where
- 4 sites in United States
- Sponsor
- Kyntra Bio
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
- Trial name
- NCT04649411
- Testing
- ferric citrate, standard of care
- Sponsor
- Keryx Biopharmaceuticals
Chronic Kidney Disease (CKD)
The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients
The study was conducted to assess safety and immunogenicity of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory…
- Trial name
- NCT05422755
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- PT. Daewoong Infion
Anemia, Kidney Failure, Chronic
Dynepo Long-Term Safety Study
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.
- Trial name
- NCT00514813
- Testing
- Dynepo
- Where
- Belgium
- Volunteers
- 152 people
- Sponsor
- Shire
Anaemia
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD).
- Trial name
- NCT02019719
- Testing
- GSK1278863
- Where
- 21 sites in Japan
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline