NCT00737477 (MISTRAL) is a Phase 3 clinical trial of Methoxy polyethylene glycol-epoetin beta in Anemia, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT00737477?

NCT00737477 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00737477?

Interventions in NCT00737477: Methoxy polyethylene glycol-epoetin beta.

Is NCT00737477 still recruiting?

NCT00737477 is currently completed. Last updated 23 June 2017.

Are results published for NCT00737477?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-06-23 · How we verify

NCT00737477: MISTRAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis

Completed Phase 3 Results posted Last updated 23 June 2017

What this trial tests

Phase 3 trial testing Methoxy polyethylene glycol-epoetin beta in Anemia in 96 participants. Completed in 31 July 2011.

Timeline

30 September 2008

Primary endpoint
31 July 2011

31 July 2011

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	30 September 2008
Primary completion	31 July 2011
Estimated completion	31 July 2011
Sites	52 locations across France

Drugs / interventions tested

Methoxy polyethylene glycol-epoetin beta (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) — full drug profile →

Conditions studied

Anemia — all drugs for Anemia →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP Primary · 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.

Group	Value	95% CI
Mircera in CKD-Related Anemia	50.0	39.0 – 61.0

Percentage of Participants With Hb Values Within Target Range During the EEP Secondary · Weeks 16 to 24

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.

At Least One Hb Value (n=80)

Group	Value	95% CI
Mircera in CKD-Related Anemia	78.8

At Least Two Hb Values (n=77)

Group	Value	95% CI
Mircera in CKD-Related Anemia	49.4

All Three Hb Values (n=74)

Group	Value	95% CI
Mircera in CKD-Related Anemia	23.0

Change in Hb Value From Baseline to the EEP Secondary · Baseline and Weeks 16 to 24

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.

Group	Value	95% CI
Mircera in CKD-Related Anemia	0.4	± 0.9

Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period Secondary · Weeks 16 to 24 and Weeks 0 to 48

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.

EEP (Weeks 16 to 24; n=80)

Group	Value	95% CI
Mircera in CKD-Related Anemia	5.9	± 4.2

Overall Study (Weeks 0 to 48; n=94)

Group	Value	95% CI
Mircera in CKD-Related Anemia	22.0	± 13.8

Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit Secondary · Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48

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.

Week 16 (n=80)

Group	Value	95% CI
Mircera in CKD-Related Anemia	37.5

Week 20 (n=76)

Group	Value	95% CI
Mircera in CKD-Related Anemia	35.5

Week 24 (n=75)

Group	Value	95% CI
Mircera in CKD-Related Anemia	44.0

Week 28 (n=73)

Group	Value	95% CI
Mircera in CKD-Related Anemia	39.7

Week 32 (n=72)

Group	Value	95% CI
Mircera in CKD-Related Anemia	44.4

Week 36 (n=68)

Group	Value	95% CI
Mircera in CKD-Related Anemia	51.5

Week 40 (n=65)

Group	Value	95% CI
Mircera in CKD-Related Anemia	44.6

Week 44 (n=63)

Group	Value	95% CI
Mircera in CKD-Related Anemia	44.4

Percentage of Participants With Cycles or Excursions Secondary · Weeks 4 to 44

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.

At Least One Cycle

Group	Value	95% CI
Mircera in CKD-Related Anemia	5.3

At Least One Excursion

Group	Value	95% CI
Mircera in CKD-Related Anemia	60.0

At Least One Up Excursion

Group	Value	95% CI
Mircera in CKD-Related Anemia	46.3

At Least One Down Excursion

Group	Value	95% CI
Mircera in CKD-Related Anemia	18.9

Percentage of Participants With Up Excursions Secondary · Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44

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.

Weeks 4 to 16

Group	Value	95% CI
Mircera in CKD-Related Anemia	31.8

Weeks 16 to 24

Group	Value	95% CI
Mircera in CKD-Related Anemia	45.5

Weeks 24 to 44

Group	Value	95% CI
Mircera in CKD-Related Anemia	22.7

Percentage of Participants With Down Excursions Secondary · Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44

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.

Weeks 4 to 16

Group	Value	95% CI
Mircera in CKD-Related Anemia	16.7

Weeks 16 to 24

Group	Value	95% CI
Mircera in CKD-Related Anemia	11.1

Weeks 24 to 44

Group	Value	95% CI
Mircera in CKD-Related Anemia	72.2

Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA Secondary · Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48

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.

Any Dose Adjustment, Weeks 4 to 20 (n=95)

Group	Value	95% CI
Mircera in CKD-Related Anemia	84.2

Decreased Dose, Weeks 4 to 20 (n=75)

Group	Value	95% CI
Mircera in CKD-Related Anemia	69.3

Increased Dose, Weeks 4 to 20 (n=75)

Group	Value	95% CI
Mircera in CKD-Related Anemia	43.3

Dose Not Performed, Weeks 4 to 20 (n=95)

Group	Value	95% CI
Mircera in CKD-Related Anemia	34.7

Any Dose Adjustment, Weeks 24 to 48 (n=76)

Group	Value	95% CI
Mircera in CKD-Related Anemia	100

Decreased Dose, Weeks 24 to 48 (n=50)

Group	Value	95% CI
Mircera in CKD-Related Anemia	74.0

Increased Dose, Weeks 24 to 48 (n=50)

Group	Value	95% CI
Mircera in CKD-Related Anemia	46.0

Dose Not Performed, Weeks 24 to 48 (n=76)

Group	Value	95% CI
Mircera in CKD-Related Anemia	30.3

Number of Dose Adjustments of Mircera/CERA Secondary · Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48

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.

Weeks 4 to 20 (n=95)

Group	Value	95% CI
Mircera in CKD-Related Anemia	2.0	± 1.3

Weeks 24 to 48 (n=76)

Group	Value	95% CI
Mircera in CKD-Related Anemia	5.6	± 1.3

Weeks 4 to 48 (n=95)

Group	Value	95% CI
Mircera in CKD-Related Anemia	3.3	± 2.0

Absolute Change in Dose of Mircera/CERA by Study Week Secondary · Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

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.

Week 4, Dose Decrease (n=25)

Group	Value	95% CI
Mircera in CKD-Related Anemia	25.8	± 11.9

Week 4, Dose Increase (n=9)

Group	Value	95% CI
Mircera in CKD-Related Anemia	37.8	± 17.2

Week 8, Dose Decrease (n=32)

Group	Value	95% CI
Mircera in CKD-Related Anemia	28.4	± 12.3

Week 8, Dose Increase (n=14)

Group	Value	95% CI
Mircera in CKD-Related Anemia	42.9	± 24.6

Week 12, Dose Decrease (n=21)

Group	Value	95% CI
Mircera in CKD-Related Anemia	24.5	± 3.5

Week 12, Dose Increase (n=8)

Group	Value	95% CI
Mircera in CKD-Related Anemia	52.5	± 21.7

Week 16, Dose Decrease (n=20)

Group	Value	95% CI
Mircera in CKD-Related Anemia	24.0	± 2.6

Week 16, Dose Increase (n=8)

Group	Value	95% CI
Mircera in CKD-Related Anemia	47.5	± 29.0

Percent Change in Dose of Mircera/CERA by Study Week Secondary · Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

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.

Week 4, Dose Decrease (n=25)

Group	Value	95% CI
Mircera in CKD-Related Anemia	23.7	± 9.0

Week 4, Dose Increase (n=9)

Group	Value	95% CI
Mircera in CKD-Related Anemia	22.2	± 6.7

Week 8, Dose Decrease (n=32)

Group	Value	95% CI
Mircera in CKD-Related Anemia	33.3	± 22.2

Week 8, Dose Increase (n=14)

Group	Value	95% CI
Mircera in CKD-Related Anemia	21.4	± 4.9

Week 12, Dose Decrease (n=21)

Group	Value	95% CI
Mircera in CKD-Related Anemia	30.3	± 10.0

Week 12, Dose Increase (n=8)

Group	Value	95% CI
Mircera in CKD-Related Anemia	22.0	± 2.3

Week 16, Dose Decrease (n=20)

Group	Value	95% CI
Mircera in CKD-Related Anemia	41.1	± 14.0

Week 16, Dose Increase (n=8)

Group	Value	95% CI
Mircera in CKD-Related Anemia	25.6	± 7.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Continuously from Weeks -4 to 48 and/or 30 days after last dose (up to approximately 1 year overall). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mircera in CKD-Related Anemia

Serious: 48/96 (50%)

Deaths: —

Serious adverse events (60 terms)

Reaction	System	Mircera in CKD-Related Ane…
Peritonitis	Gastrointestinal disorders	—
Peritoneal infection	Infections and infestations	—
Sepsis	Infections and infestations	—
General physical health deterioration	General disorders	—
Fluid overload	Metabolism and nutrition disorders	—
Sciatica	Nervous system disorders	—
Peripheral arterial occlusive disease	Vascular disorders	—
Cholecystitis acute	Hepatobiliary disorders	—
Abdominal pain	Gastrointestinal disorders	—
Abdominal strangulated hernia	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Inguinal hernia	Gastrointestinal disorders	—
Intestinal polyp	Gastrointestinal disorders	—
Oesophagitis haemorrhagic	Gastrointestinal disorders	—
Oesophagitis ulcerative	Gastrointestinal disorders	—
Peritoneal haemorrhage	Gastrointestinal disorders	—
Pneumoperitoneum	Gastrointestinal disorders	—
Subileus	Gastrointestinal disorders	—
Umbilical hernia	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Acute coronary syndrome	Cardiac disorders	—
Angina unstable	Cardiac disorders	—
Arrhythmia	Cardiac disorders	—
Atrioventricular block	Cardiac disorders	—
Bradycardia	Cardiac disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Mircera in CKD-Related Ane…
Bronchitis	Respiratory, thoracic and mediastinal disorders	—
Hypertension	Vascular disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Oedema peripheral	General disorders	—

Most-reported serious reactions: Peritonitis, Peritoneal infection, Sepsis, General physical health deterioration, Fluid overload, Sciatica, Peripheral arterial occlusive disease, Cholecystitis acute.

Data from ClinicalTrials.gov NCT00737477 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Methoxy polyethylene glycol-epoetin beta

Trials testing the same drug.

NCT01519947 — A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participant · Phase 4 · completed
NCT01194154 — A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA) · Phase 2 · completed
NCT02547454 — An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants · completed

Other recruiting trials for Anemia

Currently open trials in the same condition.

NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

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NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00737477 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 23 June 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00737477.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing