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

NCT00642304 | Completed Phase 3 Results

• 1 other identifier: ML20937
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 23

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (5)

• Mean Change in Hb Concentration Between SVP and the EEP

  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

  EEP (Weeks 16 to 24)

• Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP

  EEP (Weeks 16 to 24)

• Percentage of Participants With Blood Transfusion

  Baseline up to Week 28

• Percentage of Participants With Dose Adjustment

  Baseline up to Week 20

Study Arms (1)

methoxy polyethylene glycol-epoetin beta

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Interventions

methoxy polyethylene glycol-epoetin beta [C.E.R.A.] DRUG

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.

methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (23)

Twenteborg Ziekenhuis

Almelo, 7609 PP, Netherlands

Location

Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

Amersfoort, 3818 ES, Netherlands

Location

Bovenij Zkhs; Cardiologie Afd.

Amsterdam, 1034 CS, Netherlands

Location

Wilhelmina Ziekenhuis; Inwendige Geneeskunde

Assen, 9401 RK, Netherlands

Location

Rode Kruis Ziekenhuis; Inwendige Geneeskunde

Beverwijk, 1942LE, Netherlands

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Reinier De Graaf Groep

Delft, 2625 AD, Netherlands

Location

Slingeland Ziekenhuis; Inwendige Geneeskunde

Doetinchem, 7009 BL, Netherlands

Location

Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde

Dordrecht, 3318 AT, Netherlands

Location

Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde

Drachten, 9202 NN, Netherlands

Location

Oosterscheldeziekenhuis

Goes, 4462 RA, Netherlands

Location

Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde

Gouda, 2803 HH, Netherlands

Location

Atrium Medisch Centrum; Nephrology

Heerlen, 6419 PC, Netherlands

Location

Bethesda Hospital; Internal Medicine

Hoogeveen, 7909, Netherlands

Location

Leiden University Medical Center; Nierziekten

Leiden, 2333 ZA, Netherlands

Location

Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde

Leiderdorp, 2353 GA, Netherlands

Location

Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

Maastricht, 6229 HX, Netherlands

Location

Academisch Ziekenhuis St. Radboud; Nierziekten Afd.

Nijmegen, 6525 GA, Netherlands

Location

Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde

Rotterdam, 3015 GD, Netherlands

Location

Mc Rijnmond Zuid - Locatie Clara; Infectieziekten

Rotterdam, 3078 HT, Netherlands

Location

Ikazia Ziekenhuis; Interne Oncologie

Rotterdam, 3083 AN, Netherlands

Location

Zorgsaam Ziekenhuis

Terneuzen, 4535 PA, Netherlands

Location

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 25, 2008
• Study Start: March 27, 2008
• Primary Completion: December 9, 2009
• Study Completion: December 9, 2009
• Last Updated: June 26, 2018
• Results First Posted: November 7, 2016

Record last verified: 2018-03

Locations

NL (23)