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Anemia of Chronic Kidney DiseasePhase 3NCT03428594

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

A Phase 3 study testing CKD-11101 and NESP 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 intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis. 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 and NESP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
No sites listed yet
Study dates
Jun 2015to Jun 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 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

About this study

Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluation the Efficacy and Safety of Intravenous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Receiving Hemodialysis

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.

Read the detailed description

This study was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who had renal anemia receiving hemodialysis.

The selection criteria are evaluated for 19-year-old patients who receive stable hemodialysis treatment for 3 months or more in patients with chronic renal failure. After completion of the stabilization period of 12 to 16 weeks for Darbepoetin Alfa, the subjects with the mean Hb levels of 10 to 12g/dl measured during the baseline visit and 0 week visit are randomized to the test and control groups in a 1:1 ratio during the randomization visit. They have a 20-week maintenance period and a 4-week evaluation period.

Being tested
CKD-11101, NESP

What participants receive

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

  • CKD-11101Biological

  • NESPBiological

Study groups in NCT03428594
Study groupRoleWhat they receive
CKD-11101ExperimentalThe 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
NESPActive 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

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 to Reference Drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Weeks -4 - 0) will be conducted.

    Measured: ([Mean of hemoglobin level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 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 to Reference Drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.

    Measured: Weeks 20 - 24

Secondary outcomes (6)

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

    Ratio of subjects who maintain target level of hemoglobin: Compare the number of subjects who do not deviate from target level of hemoglobin during the evaluation period between groups

    Measured: Weeks 20 - 24

  2. Mean hemoglobin levels at Weeks 20 and 24

    Mean hemoglobin level at Weeks 20 and 24: Compare mean hemoglobin level at Weeks 20 and 24 between groups

    Measured: Weeks 20, 24

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

    Compare ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period between groups (interval of every 2 weeks)

    Measured: Weeks 0 - 24

  4. Ratio of subjects who changed dose during maintenance period and evaluation period

    Ratio of subjects who changed dose: Compare ratio of subjects who change dose during maintenance period and evaluation period between groups

    Measured: Weeks 0 - 24

  5. Ratio of subjects who receive transfusion during maintenance period and evaluation period

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

    Measured: Weeks 0 - 24

  6. Number of red blood cell transfusion per subject during maintenance period and evaluation period

    Number of red blood cell transfusion per subject: Compare number of red blood cell transfusion per subject during maintenance 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 posted9 Feb 2018
  2. Study startJun 2015
  3. Primary completionJun 2017
  4. Study completionJun 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
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03428594
Sponsor's protocol ID
136Ane14004
Status last verified
Feb 2018
First submitted
29 Jan 2018
Last updated
9 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CKD-11101 and NESP 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 8 inclusion and 9 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 9 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 level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 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 NCT03428594, which also lists 1 linked publication.

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 9 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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