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AnemiaPhase 3NCT00546481

A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] and Epoetin in people with Anemia, run by Hoffmann-La Roche at 7 sites in South Korea.

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

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] and Epoetin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
7 sitesSouth Korea
Study dates
Nov 2007to Dec 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Who cannot join

  • previous therapy with epoetin within 8 weeks prior to screening;
  • overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
  • RBC transfusions within 8 weeks before screening or during screening period;
  • active malignant disease except non-melanoma skin cancer.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Study site

    Gyeonggi-do, 431-070

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 134-701

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 405-760

  • Study site

    Sungnam, 463-802

Other trials in South Korea

About this study

Official title: An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions
Anemia
Being tested
methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera], Epoetin
Medical subject headings
Anemia

What participants receive

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

  • methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]Drug

    0.6 micrograms/kg every 2 weeks

  • EpoetinDrug

    As prescribed, iv, 3 times weekly

Study groups in NCT00546481
Study groupRoleWhat they receive
Correction Phase: CERAExperimentalNot described
Receives: Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
Correction Phase: Epoetin BetaActive comparatorNot described
Receives: Drug: Epoetin

What is being measured

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

  1. Percentage of Participants Who Achieved Hemoglobin Response up to Week 24

    Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented

    Measured: Up to Week 24

Secondary outcomes (7)

  1. Mean Change From Baseline in Hemoglobin Concentration at Week 24

    Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value

    Measured: From Baseline (Day 1) to Week 24

  2. Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24

    Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.

    Measured: Up to Week 24

  3. Number of Participants Who Received Red Blood Cells Transfusions up to Week 49

    The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)

    Measured: Up to Week 49

  4. Number of Participants With Any Adverse Events and Serious Adverse Events

    An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.

    Measured: Up to Week 49

  5. Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.

    Measured: From Baseline (Day 1) to Week 24

  6. Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24

    Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.

    Measured: From Baseline (Day 1) to Week 24

  7. Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24

    Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.

    Measured: Up to Week 24

Timeline

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

  1. First posted19 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

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
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00546481
Sponsor's protocol ID
ML20884
Status last verified
Aug 2016
First submitted
18 Oct 2007
Last updated
19 Sep 2016

Publications

  • Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, Chung W, Kim S, Huh W, Oh HY, Choi BS, Yang CW, Kim S. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis. J Korean Med Sci. 2014 Jan;29(1):76-83. doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26.

    PubMed 24431909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] and Epoetin in people with Anemia, run by Hoffmann-La Roche at 7 sites in South Korea.

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 3 inclusion and 4 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 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 18 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 (time frame: Up to Week 24). 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 NCT00546481, 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 19 Sep 2016.

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