AzTrials
AzTrials

AnemiaPhase 3CARISMANCT00699348

A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) in people with Anemia, run by Hoffmann-La Roche at 60 sites in Italy.

Completed

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

Official record
Search all trials

Trial summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. 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 (C.E.R.A.)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
60 sitesItaly
Study dates
Jul 2008to Jul 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;
  • Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
  • Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.

Who cannot join

  • Transfusion of red blood cells during previous 2 months;
  • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
  • Active malignant disease (except non-melanoma skin cancer).

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

Italy60 sites

  • Study site

    Acireale, 95024

  • Study site

    Ancona, 60121

  • Study site

    Anzio, 00042

  • Study site

    Arenzano, 16011

  • Study site

    Ascoli Piceno, 63100

  • Study site

    Avellino, 83100

  • Study site

    Benevento, 82100

  • Study site

    Bollate, 20021

  • Study site

    Borgomanero, 28021

  • Study site

    Brescia, 25123

  • Study site

    Brindisi, 72100

  • Study site

    Cagliari, 09100

  • Study site

    Castellammare di Stabia, 80053

  • Study site

    Catania, 95124

  • Study site

    Catania, 95126

  • Study site

    Cernusco sul Naviglio, 20063

  • Study site

    Chieri, 10023

  • Study site

    Chieti, 66013

  • Study site

    Civitavecchia, 00053

  • Study site

    Cosenza, 87100

  • Study site

    Ferrara, 44100

  • Study site

    Florence, 50011

  • Study site

    Florence, 50100

  • Study site

    Foggia, 71100

  • Study site

    Genova, 16132

  • Study site

    La Spezia, 19124

  • Study site

    Lecco, 23900

  • Study site

    Legnano, 20025

  • Study site

    Lido di Ostia, 00121

  • Study site

    Lodi, 26900

  • Study site

    Lucera, 71036

  • Study site

    Mantua, 46100

  • Study site

    Matera, 75100

  • Study site

    Milan, 20142

  • Study site

    Milazzo, 98057

  • Study site

    Montevarchi, 52025

  • Study site

    Naples, 80131

  • Study site

    Naples, 80137

  • Study site

    Nocera Inferiore, 84014

  • Study site

    Novara, 28100

  • Study site

    Nuoro, 08100

  • Study site

    Palermo, 90127

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06126

  • Study site

    Piacenza, 29100

  • Study site

    Pisa, 56100

  • Study site

    Ravenna, 48100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00133

  • Study site

    Roma, 00149

  • Study site

    Roma, 00161

  • Study site

    Roma, 00189

  • Study site

    San Daniele del Friuli, 33038

  • Study site

    San Miniato, 56028

  • Study site

    Sassari, 07100

  • Study site

    Taranto, 74100

  • Study site

    Torino, 10126

  • Study site

    Udine, 33100

  • Study site

    Verona, 37126

  • Study site

    Vicenza, 36100

Other trials in Italy

About this study

Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Conditions
Anemia
Being tested
Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
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 (C.E.R.A.)Drug

    Also called Mircera

    Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.

Study groups in NCT00699348
Study groupRoleWhat they receive
C.E.R.A.ExperimentalNot described
Receives: Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

What is being measured

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

  1. Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

    Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.

    Measured: Week 17 up to Week 24

Secondary outcomes (5)

  1. Change in Hemoglobin Concentration Between Reference SVP and EEP

    The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.

    Measured: Week -4 up to Week 0 and Week 17 up to Week 24

  2. Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range

    Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.

    Measured: Week 17 up to Week 24

  3. Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

    Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.

    Measured: Week 17 up to Week 24

  4. Percentage of Participants Requiring Any Dose Adjustment

    Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.

    Measured: Week 1 up to Week 16 and Week 17 up to Week 24

  5. Number of Participants With Red Blood Cell Transfusion During the Study

    Number of participant who underwent red blood cell transfusion during the study was reported.

    Measured: Week -4 up to Week 52

Timeline

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

  1. First posted18 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2010
  4. Study completionJul 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
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00699348
Sponsor's protocol ID
ML21438
Other IDs
2007-005799-15
Acronym
CARISMA
Status last verified
Mar 2016
First submitted
17 Jun 2008
Last updated
6 Apr 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

  • Locatelli F, Mandolfo S, Menegato Adorati M, Villa G, Tarchini R, Pizzarelli F, Conte F, Guastoni C, Ricciardi B, Crotta A. Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia. J Nephrol. 2013 Nov-Dec;26(6):1114-21. doi: 10.5301/jn.5000251. Epub 2013 Sep 13.

    PubMed 24052462

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) in people with Anemia, run by Hoffmann-La Roche at 60 sites in Italy.

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 3 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 60 sites in Italy. 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 Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range (time frame: Week 17 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 NCT00699348, 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 6 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in