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AnemiaPhase 3MERCURNCT00559637

A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta in people with Anemia, run by Hoffmann-La Roche at 50 sites in Germany.

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 and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
50 sitesGermany
Study dates
Jan 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

  • chronic renal anemia;
  • hemoglobin value less than or equal to (<=) 10.5 grams/deciliter (g/dL).

Who cannot join

  • prior ESA therapy during previous 3 months;
  • acute or chronic bleeding requiring therapy during previous 2 months;
  • transfusion of red blood cells during previous 2 months;
  • active malignant disease (except non-melanoma skin cancer).

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

Germany50 sites

  • Study site

    Ansbach, 91522

  • Study site

    Arnsberg, 59759

  • Study site

    Bad Aibling, 83043

  • Study site

    Berlin, 10115

  • Study site

    Bischofswerda, 01877

  • Study site

    Bonn, 53179

  • Study site

    Cologne, 50937

  • Study site

    Cologne, 51109

  • Study site

    Dieburg, 64807

  • Study site

    Dortmund, 44135

  • Study site

    Düsseldorf, 40211

  • Study site

    Emsdetten, 48282

  • Study site

    Frankfurt, 60528

  • Study site

    Friedberg, 86316

  • Study site

    Grimma, 04668

  • Study site

    Hamburg, 21073

  • Study site

    Hamburg, 22391

  • Study site

    Heidelberg, 69120

  • Study site

    Hilden, 40721

  • Study site

    Homburg, 66424

  • Study site

    Hoyerswerda, 02977

  • Study site

    Jena, 07743

  • Study site

    Kaiserslautern, 67655

  • Study site

    Loerrach, 79539

  • Study site

    Lübeck, 23562

  • Study site

    Ludwigslust, 19288

  • Study site

    Lünen, 44534

  • Study site

    Mainz, 55131

  • Study site

    Malente, 23714

  • Study site

    Mettmann, 40822

  • Study site

    Mühlacker, 75417

  • Study site

    München, 81545

  • Study site

    Regensburg, 93053

  • Study site

    Rheine, 48431

  • Study site

    Saarlouis, 66740

  • Study site

    Schwandorf in Bayern, 92421

  • Study site

    Schweinfurt, 97421

  • Study site

    Sindelfingen, 71063

  • Study site

    Sinsheim, 74889

  • Study site

    Tangermünde, 39590

  • Study site

    Trier, 54290

  • Study site

    Tübingen, 72076

  • Study site

    Ulm, 89077

  • Study site

    Velbert, 42549

  • Study site

    Wetzlar, 35578

  • Study site

    Wiesloch, 69168

  • Study site

    Worms, 67547

  • Study site

    Würzburg, 97072

  • Study site

    Würzburg, 97080

  • Study site

    Zwickau, 08056

Other trials in Germany

About this study

Official title: Single-arm, Open Study to Investigate the Efficacy, Safety and Tolerability of Monthly Subcutaneously Administered C.E.R.A. in Patients With Renal Anemia Not Yet Subject to Dialysis and Not Yet Permanently Treated With ESAs

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.

Conditions
Anemia
Being tested
Methoxy polyethylene glycol-epoetin beta
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 betaDrug

    Also called Mircera

    Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.

Study groups in NCT00559637
Study groupRoleWhat they receive
Methoxy polyethylene glycol-epoetin betaExperimentalMethoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
Receives: Drug: Methoxy polyethylene glycol-epoetin beta

What is being measured

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

  1. Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)

    Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.

    Measured: Evaluation phase (Months 8 and 9)

  2. Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL

    Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.

    Measured: Evaluation phase (Months 8 and 9)

  3. Change From Baseline in Hemoglobin Value to the Evaluation Phase

    The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.

    Measured: Baseline, evaluation phase (Months 8 and 9)

Secondary outcomes (5)

  1. Duration of Hemoglobin Values in the Range of 11-12 g/dL

    The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.

    Measured: Baseline to Month 9

  2. Duration of Hemoglobin Values in the Range of 11-13 g/dL

    The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.

    Measured: Baseline to Month 9

  3. Time to Increase of Hemoglobin Value to Over 11 g/dL

    The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL.

    Measured: Baseline to Month 9

  4. Total Number of Dose Adjustments

    A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment.

    Measured: Baseline until Month 8

  5. Total Number of Red Blood Cell (RBC) Transfusions

    RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).

    Measured: Baseline to Month 9

Timeline

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

  1. First posted16 Nov 2007 (estimated)
  2. Study startJan 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
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559637
Sponsor's protocol ID
ML20888
Other IDs
2007-000126-46
Acronym
MERCUR
Status last verified
Mar 2016
First submitted
15 Nov 2007
Last updated
6 Apr 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta in people with Anemia, run by Hoffmann-La Roche at 50 sites in Germany.

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 2 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany. 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 6 Apr 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 With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL) (time frame: Evaluation phase (Months 8 and 9)). The study lists 3 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 NCT00559637.

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 6 Apr 2016.

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