Clinical trial NCT03428594: CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 403
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, multi-center, phase 3 clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Changed amount of mean hemoglobin level in evaluation period compared to the baseline
timeFrame: ([Mean of hemoglobin level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 0])
measure: Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24
timeFrame: Weeks 20 - 24
Secondary outcomes:
measure: Ratio of subjects who achieve target level of hemoglobin during the evaluation period
timeFrame: Weeks 20 - 24
measure: Mean hemoglobin levels at Weeks 20 and 24
timeFrame: Weeks 20, 24
measure: Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)
timeFrame: Weeks 0 - 24
measure: Ratio of subjects who changed dose during maintenance period and evaluation period
timeFrame: Weeks 0 - 24
measure: Ratio of subjects who receive transfusion during maintenance period and evaluation period
timeFrame: Weeks 0 - 24
measure: Number of red blood cell transfusion per subject during maintenance period and evaluation period
timeFrame: Weeks 0 - 24
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center, College of Medicine, Univ. of Ulsan
name: Su-Kil Park, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: