Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

NCT00517881 | Terminated Phase 3 Results

• 2 other identifiers: ML209442006-006523-40
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 14

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range

  Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.

  Week 17 up to Week 24

Secondary Outcomes (6)

• Change in Hemoglobin Concentration Between Reference (SVP) and EEP

  Week 17 up to Week 24

• Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

  Week 17 up to Week 24

• Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

  Week 17 up to Week 24

• Percentage of Participants Requiring Any Dose Adjustment

  Week 1 up to Week 16 and Week 17 up to Week 24

• Percentage of Participants With Red Blood Cell Transfusion During the Study

  Week 0 up to Week 24

Study Arms (1)

C.E.R.A.

EXPERIMENTAL

Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

Interventions

Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) DRUG

Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.

Also known as: Mircera

C.E.R.A.

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
• Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
• Adequate iron status (serum ferritin greater than \[\>\] 100 nanogram per milliliter and Transferrin Saturation \>20 percent \[%\] or hypochromic red cells less than \[\<\] 10%)
• Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

You may not qualify if:

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
• Acute or chronic bleeding
• Active malignant disease (except non-melanoma skin cancer)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (14)

Unknown Facility

Danderyd, 18288, Sweden

Location

Unknown Facility

Eksjö, 57581, Sweden

Location

Unknown Facility

Eskilstuna, 63188, Sweden

Location

Unknown Facility

Gävle, 80187, Sweden

Location

Unknown Facility

Gothenburg, 41345, Sweden

Location

Unknown Facility

Gothenburg, S-402 76, Sweden

Location

Unknown Facility

Huddinge, 14186, Sweden

Location

Unknown Facility

Jönköping, 55185, Sweden

Location

Unknown Facility

Kristianstad, 29185, Sweden

Location

Unknown Facility

Skellefteå, S-931 86, Sweden

Location

Unknown Facility

Stockholm, 17176, Sweden

Location

Unknown Facility

Umeå, 90185, Sweden

Location

Unknown Facility

Värnamo, 33185, Sweden

Location

Unknown Facility

Västervik, 59381, Sweden

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

The study was terminated early due to the slow recruitment rate.

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: August 16, 2007
• First Posted: August 17, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 27, 2016
• Results First Posted: May 27, 2016

Record last verified: 2016-04

Locations

SE (14)