Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis

NCT02596945 | Completed Results

• 1 other identifier: ML22000
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.

Conditions

Renal Impairment; Renal Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)

  Month 7 to Month 9

Secondary Outcomes (2)

• Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)

  Month 7 to Month 9

• Average Duration in Days Mircera Was Administered at a Stable Dose

  Up to 9 months

Study Arms (1)

Peritoneal Dialysis participants

Participants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 months.

Drug: Methoxy polyethylene glycol epoetin beta

Interventions

Methoxy polyethylene glycol epoetin beta DRUG

Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).

Also known as: Mircera

Peritoneal Dialysis participants

Eligibility Criteria

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

Study Population

Participants on peritoneal dialysis who are in need of ESA therapy and have been prescribed methoxy polyethylene glycol beta by the doctor

You may qualify if:

• Participants on peritoneal dialysis
• Need for Erythropoiesis Stimulating Agent (ESA) therapy
• Prescription of methoxy polyethylene glycol epoetin beta by the doctor

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.

Mettmann, 40822, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital 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: November 3, 2015
• First Posted: November 4, 2015
• Study Start: July 31, 2009
• Primary Completion: February 28, 2011
• Study Completion: February 28, 2011
• Last Updated: July 2, 2017
• Results First Posted: January 13, 2016

Record last verified: 2017-05

Locations

DE (1)