An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant

NCT ID: NCT02538107

Last Updated: 2017-06-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-11-30

Brief Summary

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This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.

Detailed Description

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Conditions

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Anemia, Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney Transplant Participants

Participants with kidney transplant and a chronic kidney disease who were receiving methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care.

Methoxy-polyethyleneglycol epoetin beta

Intervention Type DRUG

Interventions

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Methoxy-polyethyleneglycol epoetin beta

Intervention Type DRUG

Other Intervention Names

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Mircera

Eligibility Criteria

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Inclusion Criteria

* Participants with kidney transplant and a chronic kidney disease (CKD), who need erythropoiesis stimulating agent (ESA) therapy as part of their medical care and prescribed methoxy polyethyleneglycol-epoetin beta by the doctor.
* The transplant should function regularly and without need of continuous dialysis treatment at inclusion and also during the documentation period of this study according to treating physician's prognosis.

Exclusion Criteria

* Kidney transplantation dates back less than 3 months. Acute decrease of hemoglobin (Hb) before enrollment, defined as decrease of greater than or equal to (\>/=) 2 g/dL between two sequential values.
* Administration of other ESA therapies during the observation period.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen

Hannoversch Münden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML21386

Identifier Type: -

Identifier Source: org_study_id

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