Clinical trial NCT03431623: CKD-11101 Phase 3 SC Study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis
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: 2018-02-13
Enrollment: 248
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 subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.

Detailed 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 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.

Eligibility criteria: * Inclusion Criteria

  1. Patients with 19 years of age or older
  2. Patients with chronic renal failure of stage 3 or above who are not on dialysis
  3. Patients with the Hb levels of 8 to 10g/dl measured at screening
  4. Patients with enough body iron stores who meet the following item:

     -Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
  5. Patients who have provided written consent to participate in the clinical trial voluntarily
* Exclusion Criteria

  1. Patients who are expected to need dialysis within a year or patients with rapidly progressive chronic renal failure
  2. Patients who have received drug treatment such as erythropoiesis stimulating agent for the purpose of correcting anemia within 12 weeks prior to screening
  3. Patients who have received red blood cell transfusion within 12 weeks prior to screening
  4. Patients with uncontrolled hypertension
  5. Patients who had hypersensitivity to erythropoietin agents
  6. Patients who had known hypersensitivity to mammalian cell-derived products or additives
  7. Patients with history of severe cardiovascular diseases
  8. Patients whose anemia is not caused by chronic renal failure or may affect anemia correction including the following conditions:
  9. Patients whose AST/ALT test results performed at screening exceeds twice of normal upper limit
  10. Patients who have experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent

Primary outcomes:
measure: Changed amount of mean hemoglobin level in evaluation period compared to the baseline
timeFrame: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 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
timeFrame: Weeks 20 - 24
measure: Days taken to reach target level of hemoglobin
timeFrame: Days taken to reach up to 24 weeks
measure: Mean hemoglobin level for each week
timeFrame: Weeks 4, 8, 12, 16, 20, 24, and 52
measure: Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
timeFrame: Weeks 20, 24, and 52
measure: Ratio of subjects who receive transfusion
timeFrame: Weeks 0 - 24
Other outcomes:
Locations:
Study officials:
affiliation: yangch@catholic.ac.kr
name: Chul-Woo Yang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Ha Chung B, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, Kim YW, Kim SW, Lee KW, Kang GW, An WS, Shin GT, Han S, Yang CW. Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. Curr Med Res Opin. 2019 Jun;35(6):1111-1118. doi: 10.1080/03007995.2018.1560134. Epub 2019 Jan 17.