CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluation the Efficacy and Safety of Intravenous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Receiving Hemodialysis

The aim of this study was to compare and evaluate efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.

Study Overview

• Status: Completed
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Biological: CKD-11101; Biological: NESP

Detailed Description

This study was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who had renal anemia receiving hemodialysis.

The selection criteria are evaluated for 19-year-old patients who receive stable hemodialysis treatment for 3 months or more in patients with chronic renal failure. After completion of the stabilization period of 12 to 16 weeks for Darbepoetin Alfa, the subjects with the mean Hb levels of 10 to 12g/dl measured during the baseline visit and 0 week visit are randomized to the test and control groups in a 1:1 ratio during the randomization visit. They have a 20-week maintenance period and a 4-week evaluation period.

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Inclusion Criteria

  1. Patients with 19 years of age or older
  2. Patients with anemia in chronic renal failure

  3. Patients who started hemodialysis more than 3 months ago and receive appropriate hemodialysis, satisfying the following criterion:

     -Kt/V is ≥ 1.2 or Urea reduction ratio is ≥ 65%

  4. Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits

  5. Patients with enough body iron stores who meet the following item:

     -Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%

  6. Patients who have provided written consent to participate in the trial voluntarily

• Exclusion Criteria

  1. Patients with uncontrolled hypertension
  2. Patients who had hypersensitivity to erythropoietin agents
  3. Patients who had known hypersensitivity to mammalian cell-derived products or diluting agents
  4. Patients with history of severe cardiovascular diseases
  5. Patients who have received red blood cell transfusion or hormone therapy for anemia correction within 12 weeks prior to randomization
  6. Patients whose anemia is not caused by chronic renal failure or may affect anemia correction
  7. Patients whose AST/ALT test results performed at screening exceed twice of normal upper limit
  8. Patients who had experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
  9. Patients who have been planned to change the dialysis method

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-11101; The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.	Biological: CKD-11101
Active Comparator: NESP; The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.	Biological: NESP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed amount of mean hemoglobin level in evaluation period compared to the baseline	The equivalence test on mean hemoglobin level of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Weeks -4 - 0) will be conducted.	([Mean of hemoglobin level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 0])
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24	The equivalence test on mean administration dose of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.	Weeks 20 - 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of subjects who achieve target level of hemoglobin during the evaluation period	Ratio of subjects who maintain target level of hemoglobin: Compare the number of subjects who do not deviate from target level of hemoglobin during the evaluation period between groups	Weeks 20 - 24
Mean hemoglobin levels at Weeks 20 and 24	Mean hemoglobin level at Weeks 20 and 24: Compare mean hemoglobin level at Weeks 20 and 24 between groups	Weeks 20, 24
Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)	Compare ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period between groups (interval of every 2 weeks)	Weeks 0 - 24
Ratio of subjects who changed dose during maintenance period and evaluation period	Ratio of subjects who changed dose: Compare ratio of subjects who change dose during maintenance period and evaluation period between groups	Weeks 0 - 24
Ratio of subjects who receive transfusion during maintenance period and evaluation period	Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during maintenance period and evaluation period between groups	Weeks 0 - 24
Number of red blood cell transfusion per subject during maintenance period and evaluation period	Number of red blood cell transfusion per subject: Compare number of red blood cell transfusion per subject during maintenance period and evaluation period between groups	Weeks 0 - 24

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Su-Kil Park, M.D.,Ph.D., Asan Medical Center, College of Medicine, Univ. of Ulsan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia
• Other Study ID Numbers: 136Ane14004