Clinical trial NCT00737477: A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-08-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
timeFrame: Weeks 16 to 24
Secondary outcomes:
measure: Percentage of Participants With Hb Values Within Target Range During the EEP
timeFrame: Weeks 16 to 24
measure: Change in Hb Value From Baseline to the EEP
timeFrame: Baseline and Weeks 16 to 24
measure: Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
timeFrame: Weeks 16 to 24 and Weeks 0 to 48
measure: Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
timeFrame: Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Percentage of Participants With Cycles or Excursions
timeFrame: Weeks 4 to 44
measure: Percentage of Participants With Up Excursions
timeFrame: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
measure: Percentage of Participants With Down Excursions
timeFrame: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
measure: Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA
timeFrame: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
measure: Number of Dose Adjustments of Mircera/CERA
timeFrame: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
measure: Absolute Change in Dose of Mircera/CERA by Study Week
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Percent Change in Dose of Mircera/CERA by Study Week
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Percentage of Participants Requiring Blood Transfusions
timeFrame: Weeks 0 to 48
Other outcomes:
Locations:
city: Ajaccio
country: France
facility: Ch Notre Dame Misericorde; Hemodialyse
city: Annonay
country: France
facility: Centre Hospitalier; Hemodialyse
city: Arras
country: France
facility: Ch D Arras; Nephrologie
city: Auxerre
country: France
facility: Ch D Auxerre; Nephrologie Hemodialyse
city: Besancon
country: France
facility: CHU Saint Jacques; Centre De Dialyse
city: Beuvry
country: France
facility: Ch Germon Et Gauthier; Hemodialyse
city: Bordeaux
country: France
facility: Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
city: Cabestany
country: France
facility: Centre D Hemodialyse Saint Roch
city: Caen
country: France
facility: Hopital Clemenceau; Nephrologie Hemodialyse
city: Cannes
country: France
facility: Hôpital Des Brousailles; Service de Néphrologie
city: Chalon Sur Saone
country: France
facility: CH William Morey; Nephrologie
city: Chambery
country: France
facility: Ch De Chambery; Nephrologie
city: Charleville Mezieres
country: France
facility: Hopital Manchester; Nephrologie Hemodialyse
city: Chartres
country: France
facility: Ch Hotel Dieu; Nephrologie
city: Cherbourg Octeville
country: France
facility: Ch Du Cotentin Site De Cherbourg; Nephrologie
city: Colmar
country: France
facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse
city: Creil
country: France
facility: Ch Laennec; Nephrologie Hemodialyse
city: Dijon
country: France
facility: Hopital Du Bocage; Nephrologie
city: Dunkerque
country: France
facility: Ch De Dunkerque; Nephrologie
city: Evreux
country: France
facility: Chi Eure Seine D Evreux; Nephrologie
city: La Tronche
country: France
facility: Agduc Muller
city: Le Petit Quevilly
country: France
facility: Anider; Pharmacie
city: Lille
country: France
facility: Hopital Calmette; Medecine General & Nephrologie Serv.
city: Lisieux
country: France
facility: Ch Robert Bisson; Nephrologie
city: Lyon
country: France
facility: Aural
city: Melun
country: France
facility: Hopital Marc Jacquet; Nephrologie Hemodialyse
city: Metz
country: France
facility: Hopital Saint Andre; Nephrologie
city: Nantes
country: France
facility: Echo Nantes Confluent; Uad Montfort
city: Niort
country: France
facility: Ch Georges Renon; Nephrologie Hemodialyse
city: Orleans
country: France
facility: Hopital de La Source; Service de Nephrologie & Hemodialyse
city: Paris
country: France
facility: Unite Autodialyse Paris 14; Dialyse A Domicile
city: Paris
country: France
facility: Ch Pitie Salpetriere; Nephrologie Hemodialyse
city: Paris
country: France
facility: Hopital Bichat Claude Bernard; Nephrologie
city: Paris
country: France
facility: Hopital Tenon; Nephrologie Dialyse
city: Poitiers
country: France
facility: Chu La Miletrie;Nephrologie Transplantation
city: Pontoise
country: France
facility: Ch Rene Dubos; Dialyse Peritoneale
city: Quimper
country: France
facility: Chi De Cornouaille; Nephrologie
city: Reims
country: France
facility: Hopital De La Maison Blanche; Nephrologie Hemodialyse
city: Rodez
country: France
facility: Ch De Bourran; Nephrologie Hemodialyse
city: Saint Lo
country: France
facility: Memorial France Etats Unis; Nephrologie
city: Saint-Denis
country: France
facility: Aurar; Aurar St Denis
city: Saint-Pierre
country: France
facility: Aurar
city: Saintes
country: France
facility: CH de Saintonge; Unite 1 Med Interne Nephrologie
city: Soissons
country: France
facility: Ch De Soissons; Medecine 5
city: St Maurice
country: France
facility: Hopital National; Nephrologie Hemodialyse
city: St Priest En Jarez
country: France
facility: HOPITAL NORD; NEPH Transplantation Reanimation
city: Strasbourg
country: France
facility: Hopital Civil; Nephrologie Clinique Medicale B
city: Tours
country: France
facility: Arauco; Arauco Tours Bretonneau
city: Valence
country: France
facility: Ch De Valence; Departement Medecine
city: Vandoeuvre-les-nancy
country: France
facility: ALTIR
city: Vannes
country: France
facility: CH Bretagne Atlantique de Vannes; Hemodialyse
city: Vittel
country: France
facility: Ch De Vittel; Nephrologie Hemodialyse
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: