A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

NCT01156363 | Completed Phase 4 Results

• 1 other identifier: ML22299
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief Summary

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range

  Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter \[g/dL\]) throughout the treatment period were reported.

  Weeks 1 to 32

Secondary Outcomes (4)

• Mean Monthly Hb Values

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8

• Change in Hb Concentration Between Reference and Treatment Period

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8

• Mean Time Participants Spent Having Hb Concentration Within Target Range

  Weeks 1 to 32

• Percentage of Participants Requiring Dose Adjustments

  Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8

Study Arms (1)

Single Arm

EXPERIMENTAL

Procedure: Dialysis; Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

Dialysis PROCEDURE

regular haemodialysis or peritoneal dialysis

Single Arm

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

once monthly, subcutaneously or intravenously, for 32 weeks

Single Arm

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 anaemia
• haemoglobin 10.0-12.0g/dl at screening
• adequate iron status
• continuous stable ESA (erythropoietic stimulating agent) therapy for \>/= 2 months
• regular haemodialysis or regular peritoneal dialysis for \>/= 3 months

You may not qualify if:

• uncontrolled hypertension
• haemoglobinopathy
• anaemia due to haemolysis
• pure red cell aplasia (PRCA)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

New Taiepei City, Taiwan

Location

Unknown Facility

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Anemia

Interventions

Dialysis; continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 3, 2015
• Results First Posted: December 3, 2015

Record last verified: 2015-10

Locations

TW (3)