AnemiaPhase 3MISTRALNCT00737477
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
A Phase 3 study testing Methoxy polyethylene glycol-epoetin beta in people with Anemia, run by Hoffmann-La Roche at 52 sites in France.
Trial summary
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 52 sitesFrance
- Study dates
- 30 Sep 2008to 31 Jul 2011
- 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
- Adults greater than or equal to (≥) 18 years of age
- Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
- Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
Who cannot join
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
- Significant acute or chronic bleeding during previous 8 weeks
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
France52 sites
Ch Notre Dame Misericorde; Hemodialyse
Ajaccio, 20303
Centre Hospitalier; Hemodialyse
Annonay, 07103
Ch D Arras; Nephrologie
Arras, 62022
Ch D Auxerre; Nephrologie Hemodialyse
Auxerre, 89011
CHU Saint Jacques; Centre De Dialyse
Besançon, 25030
Ch Germon Et Gauthier; Hemodialyse
Beuvry, 62660
Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
Bordeaux, 33077
Centre D Hemodialyse Saint Roch
Cabestany, 66330
Hopital Clemenceau; Nephrologie Hemodialyse
Caen, 14033
Hôpital Des Brousailles; Service de Néphrologie
Cannes, 06401
CH William Morey; Nephrologie
Chalon-sur-Saône, 71100
Ch De Chambery; Nephrologie
Chambéry, 73011
Hopital Manchester; Nephrologie Hemodialyse
Charleville-Mézières, 08011
Ch Hotel Dieu; Nephrologie
Chartres, 28018
Ch Du Cotentin Site De Cherbourg; Nephrologie
Cherbourg Octeville, 50102
Hopital Louis Pasteur; Nephrologie - Hemodialyse
Colmar, 68024
Ch Laennec; Nephrologie Hemodialyse
Creil, 60109
Hopital Du Bocage; Nephrologie
Dijon, 21079
Ch De Dunkerque; Nephrologie
Dunkirk, 59385
Chi Eure Seine D Evreux; Nephrologie
Évreux, 27023
Agduc Muller
La Tronche, 38701
Anider; Pharmacie
Le Petit-Quevilly, 76143
Hopital Calmette; Medecine General & Nephrologie Serv.
Lille, 59037
Ch Robert Bisson; Nephrologie
Lisieux, 14107
Aural
Lyon, 69008
Hopital Marc Jacquet; Nephrologie Hemodialyse
Melun, 77011
Hopital Saint Andre; Nephrologie
Metz, 57003
Echo Nantes Confluent; Uad Montfort
Nantes, 44202
Ch Georges Renon; Nephrologie Hemodialyse
Niort, 79021
Hopital de La Source; Service de Nephrologie & Hemodialyse
Orléans, 45100
Unite Autodialyse Paris 14; Dialyse A Domicile
Paris, 75014
Ch Pitie Salpetriere; Nephrologie Hemodialyse
Paris, 75651
Hopital Bichat Claude Bernard; Nephrologie
Paris, 75877
Hopital Tenon; Nephrologie Dialyse
Paris, 75970
Chu La Miletrie;Nephrologie Transplantation
Poitiers, 86021
Ch Rene Dubos; Dialyse Peritoneale
Pontoise, 95300
Chi De Cornouaille; Nephrologie
Quimper, 29107
Hopital De La Maison Blanche; Nephrologie Hemodialyse
Reims, 51092
Ch De Bourran; Nephrologie Hemodialyse
Rodez, 12027
Aurar; Aurar St Denis
Saint-Denis, 97400
Memorial France Etats Unis; Nephrologie
Saint-Lô, 50009
Hopital National; Nephrologie Hemodialyse
Saint-Maurice, 94415
Aurar
Saint-Pierre, 97410
HOPITAL NORD; NEPH Transplantation Reanimation
Saint-Priest-en-Jarez, 42277
CH de Saintonge; Unite 1 Med Interne Nephrologie
Saintes, 17108
Ch De Soissons; Medecine 5
Soissons, 02209
Hopital Civil; Nephrologie Clinique Medicale B
Strasbourg, 67091
Arauco; Arauco Tours Bretonneau
Tours, 37044
Ch De Valence; Departement Medecine
Valence, 26953
ALTIR
Vandœuvre-lès-Nancy, 54511
CH Bretagne Atlantique de Vannes; Hemodialyse
Vannes, 56017
Ch De Vittel; Nephrologie Hemodialyse
Vittel, 88804
About this study
Official title: A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
- 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, CERA
Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
| Study group | Role | What they receive |
|---|---|---|
| Mircera in Renal Anemia | Experimental | Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. Receives: Drug: Methoxy polyethylene glycol-epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Measured: Weeks 16 to 24
Secondary outcomes (12)
Percentage of Participants With Hb Values Within Target Range During the EEP
During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.
Measured: Weeks 16 to 24
Change in Hb Value From Baseline to the EEP
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
Measured: Baseline and Weeks 16 to 24
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.
Measured: Weeks 16 to 24 and Weeks 0 to 48
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.
Measured: Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48
Percentage of Participants With Cycles or Excursions
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated.
Measured: Weeks 4 to 44
Percentage of Participants With Up Excursions
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44.
Measured: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Percentage of Participants With Down Excursions
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase ("up" excursions) or decrease ("down" excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44.
Measured: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.
Measured: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Number of Dose Adjustments of Mircera/CERA
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.
Measured: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Absolute Change in Dose of Mircera/CERA by Study Week
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Percent Change in Dose of Mircera/CERA by Study Week
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants.
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Percentage of Participants Requiring Blood Transfusions
The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.
Measured: Weeks 0 to 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study start30 Sep 2008
- Primary completion31 Jul 2011
- Study completion31 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737477
- Sponsor's protocol ID
- ML21421
- Other IDs
- 2008-001747-18, 2008
- Acronym
- MISTRAL
- Status last verified
- May 2017
- First submitted
- 18 Aug 2008
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00737477
- Acronym / sponsor ID
- MISTRAL / ML21421
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2008 (actual)
- Primary completion
- 31 Jul 2011 (actual)
- Study completion
- 31 Jul 2011 (actual)
- First posted
- 19 Aug 2008 (estimated)
- Results
- Posted 28 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mircera in Renal Anemia | Experimental | Drug: Methoxy polyethylene glycol-epoetin betaParticipants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults greater than or equal to (≥) 18 years of age
- Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
- Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
Key exclusion criteria (3 listed)
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
- Significant acute or chronic bleeding during previous 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methoxy polyethylene glycol-epoetin betaAlso: Mircera, CERAMircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. | Drug | Mircera in Renal Anemia |
Primary outcome
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
Time frame: Weeks 16 to 24
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
12 secondary outcomes
Percentage of Participants With Hb Values Within Target Range During the EEP
Time frame: Weeks 16 to 24
Change in Hb Value From Baseline to the EEP
Time frame: Baseline and Weeks 16 to 24
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
Time frame: Weeks 16 to 24 and Weeks 0 to 48
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
Time frame: Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48
Percentage of Participants With Cycles or Excursions
Time frame: Weeks 4 to 44
Percentage of Participants With Up Excursions
Time frame: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Percentage of Participants With Down Excursions
Time frame: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA
Time frame: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Number of Dose Adjustments of Mircera/CERA
Time frame: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Absolute Change in Dose of Mircera/CERA by Study Week
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Percent Change in Dose of Mircera/CERA by Study Week
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Percentage of Participants Requiring Blood Transfusions
Time frame: Weeks 0 to 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
52 sites in 1 country: see every site and its status.
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 52 sites in France.
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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in France. 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 28 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 Maintained Average Hb Value Within Target Range During the EEP (time frame: Weeks 16 to 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2017.