CKD-11101 Phase 3 SC Study
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Anemia of Chronic Kidney Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double-blind, multi-center, phase 3 clinical trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
This was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin Alfa in patients who had stage 3, stage 4, and stage 5 chronic renal failure not on hemodialysis or peritoneal dialysis. The selection ...
This was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin Alfa in patients who had stage 3, stage 4, and stage 5 chronic renal failure not on hemodialysis or peritoneal dialysis. The selection criteria will be evaluated in patients who are receiving anemia correction among patients with 19 years of age or older and who had anemia in chronic renal failure of stage 3 or above. Subjects who are identified to meet all inclusion criteria will be randomized to test group and control group at 1:1 ratio and go through 24-week correction period and efficacy evaluation period. During correction period and efficacy evaluation period, subjects will visit the clinical study center every 2 weeks to receive processes designated for each visit and be administered investigational product from the investigator in charge of drug administration. In the safety evaluation period, all subjects will be administered test drug for 28weeks.
Tracking Information
- NCT #
- NCT03431623
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Chul-Woo Yang, M.D., Ph.D. yangch@catholic.ac.kr