An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

NCT01940484 | Completed Results

• 1 other identifier: ML22344
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 10

Brief Summary

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

Conditions

Anemia

Outcome Measures

Primary Outcomes (12)

• Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)

  Visit 2 (Month 1)

• Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)

  Visit 3 (Month 2)

• Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)

  Visit 4 (Month 3)

• Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)

  Visit 5 (Month 4)

• Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)

  Visit 6 (Month 5)

• Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)

  Visit 7 (Month 6)

• Mean Hemoglobin Value at Visit 2 (Month 1)

  Visit 2 (Month 1)

• Mean Hemoglobin Value at Visit 3 (Month 2)

  Visit 3 (Month 2)

• Mean Hemoglobin Value at Visit 4 (Month 3)

  Visit 4 (Month 3)

• Mean Hemoglobin Value at Visit 5 (Month 4)

  Visit 5 (Month 4)

• Mean Hemoglobin Value at Visit 6 (Month 5)

  Visit 6 (Month 5)

• Mean Hemoglobin Value at Visit 7 (Month 6)

  Visit 7 (Month 6)

Secondary Outcomes (3)

• Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study

  Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)

• Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta

  Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)

• Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert

  Up to 6 months

Study Arms (1)

Chronic Renal Anemia Participants

Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months.

Drug: Methoxy polyethylene glycol epoetin beta

Interventions

Methoxy polyethylene glycol epoetin beta DRUG

Also known as: Mircera

Chronic Renal Anemia Participants

Eligibility Criteria

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

Study Population

Participants with Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).

You may qualify if:

• Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
• Participants had to be receiving an ESA prior to entering the study
• Female participants of childbearing age had to be using effective contraceptive methods

You may not qualify if:

• As per approved package insert
• Any contraindication to ESA treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Glynnwood Hospital

Benoni, 1501, South Africa

Location

Universitas Private Hospital

Bloemfontein, 9301, South Africa

Location

GVI Constantiaberg

Cape Town, 7800, South Africa

Location

Groote Schuur Hospital; Renal Unit

Cape Town, 7925, South Africa

Location

N1City Hospital

Cape Town, 7925, South Africa

Location

Dr KB Parag & Raghubir Kidney and Dialysis Centre

Durban, 4001, South Africa

Location

St Augustine Hospital / Chelmsford Medical Center; Nephrology

Durban, South Africa

Location

Mayo Clinic

Johannesburg, 1724, South Africa

Location

Sunninghill Hospital

Johannesburg, 2157, South Africa

Location

Donald Gordon Medical Centre

Johannesburg, 2193, South Africa

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-LaRoche

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: August 31, 2009
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2012
• Last Updated: July 5, 2017
• Results First Posted: April 20, 2016

Record last verified: 2017-05

Locations

ZA (10)