CKD-11101 Phase 3 SC Study

NCT03431623 | Completed Phase 3

• 1 other identifier: 136Ane14005
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

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.

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 reference drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Week 0) will be conducted.

  ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 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 reference drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.

  Weeks 20 - 24

Secondary Outcomes (5)

• Ratio of subjects who achieve target level of hemoglobin

  Weeks 20 - 24

• Days taken to reach target level of hemoglobin

  Days taken to reach up to 24 weeks

• Mean hemoglobin level for each week

  Weeks 4, 8, 12, 16, 20, 24, and 52

• Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline

  Weeks 20, 24, and 52

• Ratio of subjects who receive transfusion

  Weeks 0 - 24

Study Arms (2)

CKD-11101(Darbepoetin alfa)

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(Darbepoetin alfa)

NESP(Darbepoetin alfa)

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(Darbepoetin alfa)

Interventions

CKD-11101(Darbepoetin alfa) BIOLOGICAL

CKD-11101(Darbepoetin alfa)

NESP(Darbepoetin alfa) BIOLOGICAL

NESP(Darbepoetin alfa)

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 chronic renal failure of stage 3 or above who are not on dialysis
• Patients with the Hb levels of 8 to 10g/dl measured at screening
• 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 clinical trial voluntarily

You may not qualify if:

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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Related Publications (2)

• 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

• 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.

  PMID: 30569763 DERIVED

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chul-Woo Yang, M.D., Ph.D.

  yangch@catholic.ac.kr

  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 13, 2018
• Study Start: May 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02