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

NCT03428594 | Completed Phase 3

• 1 other identifier: 136Ane14004
• Study Type: interventional
• Target: 403
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Ratio of subjects who achieve target level of hemoglobin during the evaluation period

  Weeks 20 - 24

• Mean hemoglobin levels at Weeks 20 and 24

  Weeks 20, 24

• Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)

  Weeks 0 - 24

• Ratio of subjects who changed dose during maintenance period and evaluation period

  Weeks 0 - 24

• Ratio of subjects who receive transfusion during maintenance period and evaluation period

  Weeks 0 - 24

Study Arms (2)

CKD-11101

EXPERIMENTAL

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

NESP

ACTIVE COMPARATOR

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

Interventions

CKD-11101 BIOLOGICAL

CKD-11101

NESP BIOLOGICAL

NESP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 19 years of age or older
• Patients with anemia in chronic renal failure
• 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%
• Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits
• Patients with enough body iron stores who meet the following item:
• Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
• Patients who have provided written consent to participate in the trial voluntarily

You may not qualify if:

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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Related Publications (1)

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  PMID: 36791280 DERIVED

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Su-Kil Park, M.D.,Ph.D.

  Asan Medical Center, College of Medicine, Univ. of Ulsan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, multi-center, phase 3 clinical trial

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 9, 2018
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02