CKD-11101 Phase 3 SC Study

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Biological: NESP(Darbepoetin alfa); Biological: CKD-11101(Darbepoetin alfa)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03431623

136Ane14005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 2 patient groups

CKD-11101(Darbepoetin alfa)

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(Darbepoetin alfa)

NESP(Darbepoetin alfa)

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(Darbepoetin alfa)