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

March 28, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Twenteborg Ziekenhuis
      • Amersfoort, Netherlands, 3818 ES
        • Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
      • Amsterdam, Netherlands, 1034 CS
        • Bovenij Zkhs; Cardiologie Afd.
      • Assen, Netherlands, 9401 RK
        • Wilhelmina Ziekenhuis; Inwendige Geneeskunde
      • Beverwijk, Netherlands, 1942LE
        • Rode Kruis Ziekenhuis; Inwendige Geneeskunde
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Delft, Netherlands, 2625 AD
        • Reinier de Graaf Groep
      • Doetinchem, Netherlands, 7009 BL
        • Slingeland Ziekenhuis; Inwendige Geneeskunde
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
      • Drachten, Netherlands, 9202 NN
        • Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
      • Goes, Netherlands, 4462 RA
        • Oosterscheldeziekenhuis
      • Gouda, Netherlands, 2803 HH
        • Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
      • Heerlen, Netherlands, 6419 PC
        • Atrium Medisch Centrum; Nephrology
      • Hoogeveen, Netherlands, 7909
        • Bethesda Hospital; Internal Medicine
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center; Nierziekten
      • Leiderdorp, Netherlands, 2353 GA
        • Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
      • Maastricht, Netherlands, 6229 HX
        • Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
      • Nijmegen, Netherlands, 6525 GA
        • Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
      • Rotterdam, Netherlands, 3078 HT
        • Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia Ziekenhuis; Interne Oncologie
      • Terneuzen, Netherlands, 4535 PA
        • Zorgsaam Ziekenhuis
      • Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
EEP (Weeks 16 to 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
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.
EEP (Weeks 16 to 24)
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.
EEP (Weeks 16 to 24)
Percentage of Participants With Blood Transfusion
Time Frame: Baseline up to Week 28
Baseline up to Week 28
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.
Baseline up to Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2008

Primary Completion (Actual)

December 9, 2009

Study Completion (Actual)

December 9, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20937

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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