A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

NCT00737464 | Completed Phase 4 Results

• 1 other identifier: ML21810
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 17

Brief Summary

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. 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)

• Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)

  Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.

  Weeks 8 to 12 (Last 4 weeks of treatment period)

Secondary Outcomes (17)

• Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)

  SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)

• Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL

  Up to Week 12

• Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths

  Up to Week 14

• Mean Change From Baseline in Heart Rate Over Time

  From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12

• Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time

  From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12

Study Arms (1)

Mircera

EXPERIMENTAL

Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

Mircera

Eligibility Criteria

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

You may qualify if:

• male or female patients, \>=18 years of age;
• chronic renal anemia;
• Hb concentration 10.5g/dL - 12.5g/dL;
• continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

You may not qualify if:

• blood transfusion within the previous 2 months;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease;
• congestive heart failure (NYHA Class IV).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Manipal Institute of Nephrology and Urology; Nephrology

Bangalore, 560017, India

Location

Columbia Asia Medical Centre - Hebbal; Nephrology

Bangalore, 560024, India

Location

Tanker Foundation

Chennai, 600 037, India

Location

MIOT Institute of Nephrology ; Nephrology

Chennai, 6000089, India

Location

Madras Medical Mission Hospital

Chennai, 600037, India

Location

International Hospital

Guwahati, 781005, India

Location

Kamineni Hospitals; Nephrology

Hyderabad, 500068, India

Location

Nizam's Institute of Medical Sciences; Nephrology

Hyderabad, 500082, India

Location

Regency Hospital Ltd.; Nephrology

Kanpur, 208005, India

Location

Wockhardt Hospital and Kidney Institute; Nephrology

Kolkata, 700029, India

Location

Meerut Kidney Hospital

Meerut, 250001, India

Location

Silver Oaks Hospital; Nephrology

Mohali, 160 063, India

Location

Apex Kidney Care

Mumbai, 400080, India

Location

Lancelot Dialysis Center

Mumbai, 400092, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology

New Delhi, 110070, India

Location

Ruby Hall Clinic

Pune, 411 001, India

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 616878333

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: August 18, 2008
• First Posted: August 19, 2008
• Study Start: August 26, 2008
• Primary Completion: September 12, 2009
• Study Completion: September 12, 2009
• Last Updated: December 7, 2017
• Results First Posted: April 29, 2016

Record last verified: 2017-11

Locations

IN (17)