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Anemia of Chronic Kidney DiseasePhase 3NCT03431623

CKD-11101 Phase 3 SC Study

A Phase 3 study testing CKD-11101(Darbepoetin alfa) and NESP(Darbepoetin alfa) in people with Anemia of Chronic Kidney Disease, run by Chong Kun Dang Pharmaceutical.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Anemia of Chronic Kidney Disease
What is being tested?
CKD-11101(Darbepoetin alfa) and NESP(Darbepoetin alfa)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
No sites listed yet
Study dates
May 2015to Aug 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

About this study

Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis

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.

Read the 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.

Being tested
CKD-11101(Darbepoetin alfa), NESP(Darbepoetin alfa)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-11101(Darbepoetin alfa)Biological

  • NESP(Darbepoetin alfa)Biological

Study groups in NCT03431623
Study groupRoleWhat they receive
CKD-11101(Darbepoetin alfa)ExperimentalThe 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.
Receives: Biological: CKD-11101(Darbepoetin alfa)
NESP(Darbepoetin alfa)Active comparatorThe 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.
Receives: Biological: NESP(Darbepoetin alfa)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])

  2. 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.

    Measured: Weeks 20 - 24

Secondary outcomes (5)

  1. Ratio of subjects who achieve target level of hemoglobin

    Ratio of subjects who achieve target level of hemoglobin: Compare the number of subjects who achieve target level of hemoglobin during the evaluation period between groups

    Measured: Weeks 20 - 24

  2. Days taken to reach target level of hemoglobin

    Days taken to achieve target level of hemoglobin: Compare days taken to achieve target level of hemoglobin between groups

    Measured: Days taken to reach up to 24 weeks

  3. Mean hemoglobin level for each week

    Mean hemoglobin level for each week: Compare Weeks 4, 8, 12, 16, 20, 24, and 52 between groups

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

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

    Compare the mean change of hemoglobin level at Weeks 20, 24, and 52 compared to the baseline

    Measured: Weeks 20, 24, and 52

  5. Ratio of subjects who receive transfusion

    Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during treatment period and evaluation period between groups

    Measured: Weeks 0 - 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2018
  2. Study startMay 2015
  3. Primary completionFeb 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, multi-center, phase 3 clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03431623
Sponsor's protocol ID
136Ane14005
Status last verified
Feb 2018
First submitted
29 Jan 2018
Last updated
13 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36791280

  • 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.

    PubMed 30569763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CKD-11101(Darbepoetin alfa) and NESP(Darbepoetin alfa) in people with Anemia of Chronic Kidney Disease, run by Chong Kun Dang Pharmaceutical.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changed amount of mean hemoglobin level in evaluation period compared to the baseline (time frame: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03431623, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.

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