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

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Biological: NESP; Biological: CKD-11101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03428594

136Ane14004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 403 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

403 participants in 2 patient groups

CKD-11101

Experimental group

Description:

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.

Treatment:

Biological: CKD-11101

NESP

Active Comparator group

Description:

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.

Treatment:

Biological: NESP