A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

NCT00576628 | Completed Phase 3 Results

• 1 other identifier: ML20978
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 19

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period

  The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.

  Baseline (Week 0) and from Week 29 to Week 36

Secondary Outcomes (16)

• Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP

  From Week 29 to Week 36

• Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period

  From Week 29 to Week 36

• The Number of Participants Who Required Dose Adjustments During the Dose Titration Period

  From Week 0 to Week 28 (DTP)

• Time to Achievement of Response During the Efficacy Evaluation Period

  From Week 29 to Week 36

• Number of Participants With Red Blood Cells Transfusions.

  Up to Week 52

Study Arms (1)

C.E.R.A

EXPERIMENTAL

Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.

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

Interventions

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

Recommended starting dose 1.2 micrograms/kg sc monthly

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:

• adult patients, \>=18 years of age;
• chronic renal anemia, with no need for dialysis expected in next 3 months;
• adequate iron status.

You may not qualify if:

• previous epoetin therapy within 12 weeks prior to treatment;
• transfusion of red blood cells during 2 months prior to screening;
• significant acute or chronic bleeding such as overt gastrointestinal bleeding;
• hemolysis;
• folic acid and vitamin B 12 deficiency.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (19)

Unknown Facility

Irkutsk, 664079, Russia

Location

Unknown Facility

Khanty-Mansiysk, 628011, Russia

Location

Unknown Facility

Moscow, 117036, Russia

Location

Unknown Facility

Moscow, 123182, Russia

Location

Unknown Facility

Moscow, 125101, Russia

Location

Unknown Facility

Moscow, 129110, Russia

Location

Unknown Facility

Nizhny Novgorod, 603001, Russia

Location

Unknown Facility

Nizhny Novgorod, 603126, Russia

Location

Unknown Facility

Omsk, 644112, Russia

Location

Unknown Facility

Orenburg, 460018, Russia

Location

Unknown Facility

Rostov-on-Don, 344029, Russia

Location

Unknown Facility

Saint Petersburg, 194354, Russia

Location

Unknown Facility

Saint Petersburg, 195067, Russia

Location

Unknown Facility

Saint Petersburg, 197089, Russia

Location

Unknown Facility

Saint Petersburg, 197110, Russia

Location

Unknown Facility

Saratov, 410053, Russia

Location

Unknown Facility

Tyumen, 625023, Russia

Location

Unknown Facility

Ufa, 450005, Russia

Location

Unknown Facility

Yekaterinburg, 620102, Russia

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

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: December 18, 2007
• First Posted: December 19, 2007
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 30, 2016
• Results First Posted: November 30, 2016

Record last verified: 2016-10

Locations

RU (19)