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NCT02596945

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

Completed Results posted Last updated 2 July 2017
What this trial tests

trial testing Methoxy polyethylene glycol epoetin beta in Renal Impairment in 223 participants. Completed in 28 February 2011.

Timeline
31 July 2009
Primary endpoint
28 February 2011
28 February 2011

Quick facts

Lead sponsorHoffmann-La Roche
StatusCompleted
Study typeOBSERVATIONAL
Enrollment223
Start date31 July 2009
Primary completion28 February 2011
Estimated completion28 February 2011
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Renal Impairment or Renal Anemia of Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · Month 7 to Month 9
GroupValue95% CI
Peritoneal Dialysis Participants14.8
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) Secondary · Month 7 to Month 9
GroupValue95% CI
Peritoneal Dialysis Participants38.9
Average Duration in Days Mircera Was Administered at a Stable Dose Secondary · Up to 9 months
GroupValue95% CI
Peritoneal Dialysis Participants182.1± 122.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Methoxy polyethylene glycol epoetin beta

Trials testing the same drug.

Other recruiting trials for Renal Impairment

Currently open trials in the same condition.

Other Hoffmann-La Roche trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02596945.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing