CKD-11101 Phase 3 SC Study

NCT ID: NCT03431623

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-08-31

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.

Conditions

Anemia of Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CKD-11101(Darbepoetin alfa)

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.

Group Type: EXPERIMENTAL

CKD-11101(Darbepoetin alfa)

Intervention Type: BIOLOGICAL

NESP(Darbepoetin alfa)

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.

Group Type: ACTIVE_COMPARATOR

NESP(Darbepoetin alfa)

Intervention Type: BIOLOGICAL

Interventions

CKD-11101(Darbepoetin alfa)

Intervention Type: BIOLOGICAL

NESP(Darbepoetin alfa)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chul-Woo Yang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

yangch@catholic.ac.kr

References

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.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30569763 (View on PubMed)

Other Identifiers

136Ane14005

Identifier Type: -

Identifier Source: org_study_id