A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
- Registration Number
- NCT00737477
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mircera in Renal Anemia Methoxy polyethylene glycol-epoetin beta 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Requiring Blood Transfusions Weeks 0 to 48 The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.
Percentage of Participants With Hb Values Within Target Range During the EEP 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.
Change in Hb Value From Baseline to the EEP 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.
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period 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.
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit 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.
Percentage of Participants With Cycles or Excursions 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.
Percentage of Participants With Up Excursions 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.
Percentage of Participants With Down Excursions 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.
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA 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.
Number of Dose Adjustments of Mircera/CERA 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.
Absolute Change in Dose of Mircera/CERA by Study Week 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.
Percent Change in Dose of Mircera/CERA by Study Week 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.
Trial Locations
- Locations (52)
Arauco; Arauco Tours Bretonneau
🇫🇷Tours, France
Centre Hospitalier; Hemodialyse
🇫🇷Annonay, France
Ch Notre Dame Misericorde; Hemodialyse
🇫🇷Ajaccio, France
Hôpital Des Brousailles; Service de Néphrologie
🇫🇷Cannes, France
Hopital Louis Pasteur; Nephrologie - Hemodialyse
🇫🇷Colmar, France
Hopital Saint Andre; Nephrologie
🇫🇷Metz, France
Chi De Cornouaille; Nephrologie
🇫🇷Quimper, France
Memorial France Etats Unis; Nephrologie
🇫🇷Saint Lo, France
Hopital Tenon; Nephrologie Dialyse
🇫🇷Paris, France
Ch Pitie Salpetriere; Nephrologie Hemodialyse
🇫🇷Paris, France
Hopital Bichat Claude Bernard; Nephrologie
🇫🇷Paris, France
Hopital de La Source; Service de Nephrologie & Hemodialyse
🇫🇷Orleans, France
Aurar
🇫🇷Saint-Pierre, France
Hopital National; Nephrologie Hemodialyse
🇫🇷St Maurice, France
Hopital Civil; Nephrologie Clinique Medicale B
🇫🇷Strasbourg, France
Ch De Valence; Departement Medecine
🇫🇷Valence, France
CHU Saint Jacques; Centre De Dialyse
🇫🇷Besancon, France
Ch D Arras; Nephrologie
🇫🇷Arras, France
Ch D Auxerre; Nephrologie Hemodialyse
🇫🇷Auxerre, France
Ch Germon Et Gauthier; Hemodialyse
🇫🇷Beuvry, France
Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
🇫🇷Bordeaux, France
Centre D Hemodialyse Saint Roch
🇫🇷Cabestany, France
Hopital Clemenceau; Nephrologie Hemodialyse
🇫🇷Caen, France
CH William Morey; Nephrologie
🇫🇷Chalon Sur Saone, France
Ch Laennec; Nephrologie Hemodialyse
🇫🇷Creil, France
Hopital Manchester; Nephrologie Hemodialyse
🇫🇷Charleville Mezieres, France
Ch De Chambery; Nephrologie
🇫🇷Chambery, France
Hopital Du Bocage; Nephrologie
🇫🇷Dijon, France
Ch Hotel Dieu; Nephrologie
🇫🇷Chartres, France
Ch Du Cotentin Site De Cherbourg; Nephrologie
🇫🇷Cherbourg Octeville, France
Chi Eure Seine D Evreux; Nephrologie
🇫🇷Evreux, France
Anider; Pharmacie
🇫🇷Le Petit Quevilly, France
Hopital Calmette; Medecine General & Nephrologie Serv.
🇫🇷Lille, France
Ch De Dunkerque; Nephrologie
🇫🇷Dunkerque, France
Agduc Muller
🇫🇷La Tronche, France
Ch Robert Bisson; Nephrologie
🇫🇷Lisieux, France
Aural
🇫🇷Lyon, France
Hopital Marc Jacquet; Nephrologie Hemodialyse
🇫🇷Melun, France
Echo Nantes Confluent; Uad Montfort
🇫🇷Nantes, France
Ch Georges Renon; Nephrologie Hemodialyse
🇫🇷Niort, France
Unite Autodialyse Paris 14; Dialyse A Domicile
🇫🇷Paris, France
Chu La Miletrie;Nephrologie Transplantation
🇫🇷Poitiers, France
Ch Rene Dubos; Dialyse Peritoneale
🇫🇷Pontoise, France
Aurar; Aurar St Denis
🇫🇷Saint-Denis, France
Hopital De La Maison Blanche; Nephrologie Hemodialyse
🇫🇷Reims, France
Ch De Bourran; Nephrologie Hemodialyse
🇫🇷Rodez, France
CH de Saintonge; Unite 1 Med Interne Nephrologie
🇫🇷Saintes, France
Ch De Soissons; Medecine 5
🇫🇷Soissons, France
CH Bretagne Atlantique de Vannes; Hemodialyse
🇫🇷Vannes, France
HOPITAL NORD; NEPH Transplantation Reanimation
🇫🇷St Priest En Jarez, France
ALTIR
🇫🇷Vandoeuvre-les-nancy, France
Ch De Vittel; Nephrologie Hemodialyse
🇫🇷Vittel, France