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AnemiaPhase 3NCT00576303

A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 18 sites in Russia.

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 single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. 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 [Mircera]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
18 sitesRussia
Study dates
Apr 2008to Jun 2010
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;
  • hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
  • continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Who cannot join

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B12 deficiency.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Russia18 sites

  • Study site

    Kemerovo, 650066

  • Study site

    Krasnodar, 350086

  • Study site

    Moscow, 117049

  • Study site

    Moscow, 123182

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 127006

  • Study site

    Moscow, 129110

  • Study site

    Moscow, 129317

  • Study site

    Novosibirsk, 630087

  • Study site

    Omsk, 644111

  • Study site

    Saint Petersburg, 191015

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 196247

  • Study site

    Saint Petersburg, 197089

  • Study site

    Saint Petersburg, 197110

  • Study site

    Saint Petersburg, 198510

  • Study site

    Volzhsky, 404130

  • Study site

    Yekaterinburg, 620102

Other trials in Russia

About this study

Official title: A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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 [Mircera]
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 [Mircera]Drug

    120, 200 or 360 micrograms iv monthly (starting dose)

Study groups in NCT00576303
Study groupRoleWhat they receive
RO0503821 (C.E.R.A.), 1x/4weeksExperimentalEligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

What is being measured

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

  1. Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP

    All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24

    Measured: EEP (Week 16 to Week 24)

Secondary outcomes (5)

  1. Mean Change in Hb Concentration From Baseline to the EEP

    A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24

    Measured: Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)

  2. Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP

    All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24

    Measured: EEP (Week 16 to Week 24)

  3. Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP

    The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24

    Measured: EEP (Week 16 to Week 24)

  4. Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP

    The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44

    Measured: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)

  5. Number of Participants With Red Blood Cell Transfusion

    The number of participants who underwent red blood cell transfusion was reported

    Measured: Up to 3 years

Timeline

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

  1. First posted19 Dec 2007 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2010
  4. Study completionJun 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00576303
Sponsor's protocol ID
ML20977
Status last verified
Apr 2016
First submitted
18 Dec 2007
Last updated
26 May 2016

Publications

  • Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

    PubMed 26965694

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 18 sites in Russia.

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 4 inclusion and 5 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Russia. 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 26 May 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 Maintaining Average Hemoglobin Concentration Within +- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP (time frame: EEP (Week 16 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 NCT00576303, 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 26 May 2016.

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