Back to resultsA Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis (MISTRAL)
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methoxy polyethylene glycol-epoetin beta
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Ch Notre Dame Misericorde; Hemodialyse
- Centre Hospitalier; Hemodialyse
- Ch D Arras; Nephrologie
- Ch D Auxerre; Nephrologie Hemodialyse
- CHU Saint Jacques; Centre De Dialyse
- Ch Germon Et Gauthier; Hemodialyse
- Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
- Centre D Hemodialyse Saint Roch
- Hopital Clemenceau; Nephrologie Hemodialyse
- Hôpital Des Brousailles; Service de Néphrologie
- CH William Morey; Nephrologie
- Ch De Chambery; Nephrologie
- Hopital Manchester; Nephrologie Hemodialyse
- Ch Hotel Dieu; Nephrologie
- Ch Du Cotentin Site De Cherbourg; Nephrologie
- Hopital Louis Pasteur; Nephrologie - Hemodialyse
- Ch Laennec; Nephrologie Hemodialyse
- Hopital Du Bocage; Nephrologie
- Ch De Dunkerque; Nephrologie
- Chi Eure Seine D Evreux; Nephrologie
- Agduc Muller
- Anider; Pharmacie
- Hopital Calmette; Medecine General & Nephrologie Serv.
- Ch Robert Bisson; Nephrologie
- Aural
- Hopital Marc Jacquet; Nephrologie Hemodialyse
- Hopital Saint Andre; Nephrologie
- Echo Nantes Confluent; Uad Montfort
- Ch Georges Renon; Nephrologie Hemodialyse
- Hopital de La Source; Service de Nephrologie & Hemodialyse
- Unite Autodialyse Paris 14; Dialyse A Domicile
- Ch Pitie Salpetriere; Nephrologie Hemodialyse
- Hopital Bichat Claude Bernard; Nephrologie
- Hopital Tenon; Nephrologie Dialyse
- Chu La Miletrie;Nephrologie Transplantation
- Ch Rene Dubos; Dialyse Peritoneale
- Chi De Cornouaille; Nephrologie
- Hopital De La Maison Blanche; Nephrologie Hemodialyse
- Ch De Bourran; Nephrologie Hemodialyse
- Memorial France Etats Unis; Nephrologie
- Aurar; Aurar St Denis
- Aurar
- CH de Saintonge; Unite 1 Med Interne Nephrologie
- Ch De Soissons; Medecine 5
- Hopital National; Nephrologie Hemodialyse
- HOPITAL NORD; NEPH Transplantation Reanimation
- Hopital Civil; Nephrologie Clinique Medicale B
- Arauco; Arauco Tours Bretonneau
- Ch De Valence; Departement Medecine
- ALTIR
- CH Bretagne Atlantique de Vannes; Hemodialyse
- Ch De Vittel; Nephrologie Hemodialyse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mircera in Renal Anemia
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00737477
Brief Title
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
Acronym
MISTRAL
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 30, 2008 (Actual)
Primary Completion Date
July 31, 2011 (Actual)
Study Completion Date
July 31, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mircera in Renal Anemia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
Mircera, CERA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
Description
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.
Time Frame
Weeks 16 to 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hb Values Within Target Range During the EEP
Description
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.
Time Frame
Weeks 16 to 24
Title
Change in Hb Value From Baseline to the EEP
Description
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 Frame
Baseline and Weeks 16 to 24
Title
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
Description
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.
Time Frame
Weeks 16 to 24 and Weeks 0 to 48
Title
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
Description
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.
Time Frame
Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48
Title
Percentage of Participants With Cycles or Excursions
Description
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.
Time Frame
Weeks 4 to 44
Title
Percentage of Participants With Up Excursions
Description
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.
Time Frame
Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Title
Percentage of Participants With Down Excursions
Description
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.
Time Frame
Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Title
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA
Description
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.
Time Frame
Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Title
Number of Dose Adjustments of Mircera/CERA
Description
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.
Time Frame
Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Title
Absolute Change in Dose of Mircera/CERA by Study Week
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Title
Percent Change in Dose of Mircera/CERA by Study Week
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Title
Percentage of Participants Requiring Blood Transfusions
Description
The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.
Time Frame
Weeks 0 to 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Ch Notre Dame Misericorde; Hemodialyse
City
Ajaccio
ZIP/Postal Code
20303
Country
France
Facility Name
Centre Hospitalier; Hemodialyse
City
Annonay
ZIP/Postal Code
07103
Country
France
Facility Name
Ch D Arras; Nephrologie
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
Ch D Auxerre; Nephrologie Hemodialyse
City
Auxerre
ZIP/Postal Code
89011
Country
France
Facility Name
CHU Saint Jacques; Centre De Dialyse
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Ch Germon Et Gauthier; Hemodialyse
City
Beuvry
ZIP/Postal Code
62660
Country
France
Facility Name
Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Centre D Hemodialyse Saint Roch
City
Cabestany
ZIP/Postal Code
66330
Country
France
Facility Name
Hopital Clemenceau; Nephrologie Hemodialyse
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Des Brousailles; Service de Néphrologie
City
Cannes
ZIP/Postal Code
06401
Country
France
Facility Name
CH William Morey; Nephrologie
City
Chalon Sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Ch De Chambery; Nephrologie
City
Chambery
ZIP/Postal Code
73011
Country
France
Facility Name
Hopital Manchester; Nephrologie Hemodialyse
City
Charleville Mezieres
ZIP/Postal Code
08011
Country
France
Facility Name
Ch Hotel Dieu; Nephrologie
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Ch Du Cotentin Site De Cherbourg; Nephrologie
City
Cherbourg Octeville
ZIP/Postal Code
50102
Country
France
Facility Name
Hopital Louis Pasteur; Nephrologie - Hemodialyse
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Ch Laennec; Nephrologie Hemodialyse
City
Creil
ZIP/Postal Code
60109
Country
France
Facility Name
Hopital Du Bocage; Nephrologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Ch De Dunkerque; Nephrologie
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
Chi Eure Seine D Evreux; Nephrologie
City
Evreux
ZIP/Postal Code
27023
Country
France
Facility Name
Agduc Muller
City
La Tronche
ZIP/Postal Code
38701
Country
France
Facility Name
Anider; Pharmacie
City
Le Petit Quevilly
ZIP/Postal Code
76143
Country
France
Facility Name
Hopital Calmette; Medecine General & Nephrologie Serv.
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Ch Robert Bisson; Nephrologie
City
Lisieux
ZIP/Postal Code
14107
Country
France
Facility Name
Aural
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Marc Jacquet; Nephrologie Hemodialyse
City
Melun
ZIP/Postal Code
77011
Country
France
Facility Name
Hopital Saint Andre; Nephrologie
City
Metz
ZIP/Postal Code
57003
Country
France
Facility Name
Echo Nantes Confluent; Uad Montfort
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Ch Georges Renon; Nephrologie Hemodialyse
City
Niort
ZIP/Postal Code
79021
Country
France
Facility Name
Hopital de La Source; Service de Nephrologie & Hemodialyse
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Unite Autodialyse Paris 14; Dialyse A Domicile
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Ch Pitie Salpetriere; Nephrologie Hemodialyse
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Bichat Claude Bernard; Nephrologie
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Hopital Tenon; Nephrologie Dialyse
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Chu La Miletrie;Nephrologie Transplantation
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Ch Rene Dubos; Dialyse Peritoneale
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Chi De Cornouaille; Nephrologie
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Hopital De La Maison Blanche; Nephrologie Hemodialyse
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Ch De Bourran; Nephrologie Hemodialyse
City
Rodez
ZIP/Postal Code
12027
Country
France
Facility Name
Memorial France Etats Unis; Nephrologie
City
Saint Lo
ZIP/Postal Code
50009
Country
France
Facility Name
Aurar; Aurar St Denis
City
Saint-Denis
ZIP/Postal Code
97400
Country
France
Facility Name
Aurar
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France
Facility Name
CH de Saintonge; Unite 1 Med Interne Nephrologie
City
Saintes
ZIP/Postal Code
17108
Country
France
Facility Name
Ch De Soissons; Medecine 5
City
Soissons
ZIP/Postal Code
02209
Country
France
Facility Name
Hopital National; Nephrologie Hemodialyse
City
St Maurice
ZIP/Postal Code
94415
Country
France
Facility Name
HOPITAL NORD; NEPH Transplantation Reanimation
City
St Priest En Jarez
ZIP/Postal Code
42277
Country
France
Facility Name
Hopital Civil; Nephrologie Clinique Medicale B
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Arauco; Arauco Tours Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Ch De Valence; Departement Medecine
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
ALTIR
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CH Bretagne Atlantique de Vannes; Hemodialyse
City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
Ch De Vittel; Nephrologie Hemodialyse
City
Vittel
ZIP/Postal Code
88804
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
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