ORION Study: A Study of Monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773968
First received: October 15, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This single arm study will assess the long term maintenance of hemoglobin levels, safety and tolerability of once monthly subcutaneous Mircera in predialysis patients with chronic renal anemia. Patients currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous Mircera for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size if 100-500 individuals.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "A Single Arm, Open Label Study Evaluating Once-monthly Subcutaneous Mircera for the Maintenance of Hemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anemia"

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of Patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration between reference (SVP) and the EEP; Proportion of patients maintaining Hb levels within the range 10-12 g/dL throughout the EEP; Median time spent in Hb concentration range 10-12 g/dL [ Time Frame: Weeks 17-28 ] [ Designated as safety issue: No ]
  • Proportion of patients requiring any dose adjustment; incidence of red blood cell transfusions; adverse events, vital signs, ECG; laboratory safety paramenters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms every 4 weeks by subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >= 18 years of age;
  • chronic renal anemia;
  • continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
  • Hb concentration between 10 and 12 g/dL;
  • adequate iron status.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
  • poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
  • active malignant disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773968

Locations
Italy
Caserta, Campania, Italy, 81100
Eboli, Campania, Italy, 84025
Napoli, Campania, Italy, 80131
Nola, Campania, Italy, 80035
Solofra, Campania, Italy, 83029
Tivoli, Campania, Italy, 00019
Bologna, Emilia-Romagna, Italy, 40138
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Albano Laziale, Lazio, Italy, 00041
Civita Castellana, Lazio, Italy, 01033
Viterbo, Lazio, Italy, 01100
Savona, Liguria, Italy, 17100
Cinisello Balsamo, Lombardia, Italy, 20092
Cremona, Lombardia, Italy, 26100
Mantova, Lombardia, Italy, 46100
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
S Fermo Della Battaglia, Lombardia, Italy, 22020
Varese, Lombardia, Italy, 21100
Ancona, Marche, Italy, 60131
Pesaro, Marche, Italy, 61100
Campobasso, Molise, Italy, 86100
Alessandria, Piemonte, Italy, 15100
Chivasso, Piemonte, Italy, 10034
Barletta, Puglia, Italy, 70051
Molfetta (Ba), Puglia, Italy, 70056
Putignano, Puglia, Italy, 70017
Catania, Sicilia, Italy, 95124
Erice, Sicilia, Italy, 91016
Messina, Sicilia, Italy, 98122
Palermo, Sicilia, Italy, 90127
Lido Di Camaiore, Toscana, Italy, 55043
Pistoia, Toscana, Italy, 51100
Siena, Toscana, Italy, 53100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773968     History of Changes
Other Study ID Numbers: ML21439, 2008-003173-40
Study First Received: October 15, 2008
Last Updated: April 7, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014