CKD-11101 Phase 3 SC Study
NCT03431623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248
Last updated 2018-02-13
Summary
The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.
Conditions
- Anemia of Chronic Kidney Disease
Interventions
- BIOLOGICAL
-
CKD-11101(Darbepoetin alfa)
- BIOLOGICAL
-
NESP(Darbepoetin alfa)
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Chul-Woo Yang, M.D., Ph.D. · [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2017-02-28
- Completion
- 2017-08-31
More Related Trials
-
Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
NCT03402386 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
NCT02952092 ·Status: COMPLETED ·Phase: PHASE3
-
Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects
NCT00119587 ·Status: COMPLETED ·Phase: PHASE3
-
An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)
NCT00124098 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 2 Study of Darbepoetin Alfa Extended Dosing
NCT00527215 ·Status: COMPLETED ·Phase: PHASE2
-
A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy
NCT00907608 ·Status: TERMINATED ·Phase: NA
-
Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
NCT01652872 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug
NCT01888445 ·Status: COMPLETED ·Phase: PHASE2
-
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
NCT01576341 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
NCT00559273 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
NCT03329196 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
NCT03439137 ·Status: COMPLETED ·Phase: PHASE3
-
Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study
NCT07025460 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects
NCT00117247 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
NCT00116701 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
NCT00093977 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
NCT00925587 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure
NCT05211167 ·Status: UNKNOWN ·Phase: PHASE3
-
Desidustat in the Treatment of Anemia in CKD
NCT04012957 ·Status: COMPLETED ·Phase: PHASE3
-
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
NCT02021318 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
NCT03461146 ·Status: COMPLETED ·Phase: PHASE3
-
ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-
NCT01964196 ·Status: COMPLETED ·Phase: PHASE2
-
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
NCT00436995 ·Status: COMPLETED ·Phase: PHASE3
-
Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia
NCT00086086 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia
NCT02988973 ·Status: COMPLETED ·Phase: PHASE3