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A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

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ClinicalTrials.gov Identifier: NCT00642304
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : November 7, 2016
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Condition or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.] Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis
Actual Study Start Date : March 27, 2008
Primary Completion Date : December 9, 2009
Study Completion Date : December 9, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: methoxy polyethylene glycol-epoetin beta Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) [ Time Frame: EEP (Weeks 16 to 24) ]
    The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.


Secondary Outcome Measures :
  1. Mean Change in Hb Concentration Between SVP and the EEP [ Time Frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24) ]
    The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.

  2. Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP [ Time Frame: EEP (Weeks 16 to 24) ]
    The EEP was defined as Week 16 to Week 24.

  3. Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP [ Time Frame: EEP (Weeks 16 to 24) ]
    The EEP was defined as Week 16 to Week 24.

  4. Percentage of Participants With Blood Transfusion [ Time Frame: Baseline up to Week 28 ]
  5. Percentage of Participants With Dose Adjustment [ Time Frame: Baseline up to Week 20 ]
    A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic renal anemia
  • Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion Criteria:

  • Transfusion of red blood cells during previous 8 weeks
  • Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
  • Acute or chronic bleeding requiring therapy within previous 8 weeks
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642304


Locations
Netherlands
Twenteborg Ziekenhuis
Almelo, Netherlands, 7609 PP
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
Amersfoort, Netherlands, 3818 ES
Bovenij Zkhs; Cardiologie Afd.
Amsterdam, Netherlands, 1034 CS
Wilhelmina Ziekenhuis; Inwendige Geneeskunde
Assen, Netherlands, 9401 RK
Rode Kruis Ziekenhuis; Inwendige Geneeskunde
Beverwijk, Netherlands, 1942LE
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
Reinier De Graaf Groep
Delft, Netherlands, 2625 AD
Slingeland Ziekenhuis; Inwendige Geneeskunde
Doetinchem, Netherlands, 7009 BL
Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
Dordrecht, Netherlands, 3318 AT
Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
Drachten, Netherlands, 9202 NN
Oosterscheldeziekenhuis
Goes, Netherlands, 4462 RA
Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
Gouda, Netherlands, 2803 HH
Atrium Medisch Centrum; Nephrology
Heerlen, Netherlands, 6419 PC
Bethesda Hospital; Internal Medicine
Hoogeveen, Netherlands, 7909
Leiden University Medical Center; Nierziekten
Leiden, Netherlands, 2333 ZA
Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
Leiderdorp, Netherlands, 2353 GA
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, Netherlands, 6229 HX
Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
Nijmegen, Netherlands, 6525 GA
Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
Rotterdam, Netherlands, 3015 GD
Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
Rotterdam, Netherlands, 3078 HT
Ikazia Ziekenhuis; Interne Oncologie
Rotterdam, Netherlands, 3083 AN
Zorgsaam Ziekenhuis
Terneuzen, Netherlands, 4535 PA
Diakonessenhuis
Utrecht, Netherlands, 3582 KE
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642304     History of Changes
Other Study ID Numbers: ML20937
First Posted: March 25, 2008    Key Record Dates
Results First Posted: November 7, 2016
Last Update Posted: December 18, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics