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

NCT ID: NCT02238080

Last Updated: 2017-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-06-30

Brief Summary

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This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Methoxy Polyethylene Glycol-Epoetin Beta

Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period.

Methoxy Polyethylene Glycol-Epoetin Beta

Intervention Type DRUG

Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.

Interventions

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Methoxy Polyethylene Glycol-Epoetin Beta

Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.

Intervention Type DRUG

Other Intervention Names

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Mircera®

Eligibility Criteria

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Inclusion Criteria

* CKD participants undergoing dialysis
* Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
* Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Exclusion Criteria

* Conditions known to cause inadequate response to ESA treatment
* Anemia other than symptomatic anemia associated with CKD
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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Haemek Hospital; Nephrology

Afula, , Israel

Site Status

Barzilai Medical Centre ; Nephrology and Hypertension

Ashkelon, , Israel

Site Status

Soroka Medical Center; Nephrology

Beersheba, , Israel

Site Status

Bnai Zion MC; Nephrology

Haifa, , Israel

Site Status

Carmel Medical Center; Nephrology

Haifa, , Israel

Site Status

Wolfson MC; Nephrology

Holon, , Israel

Site Status

Shaare Zedek Medical Center; Nrphrology Dept.

Jerusalem, , Israel

Site Status

Hadassah Medical Orgainastion; Nephrology

Jerusalem, , Israel

Site Status

Meir Medical Center; Nephrology Dept.

Kfar Saba, , Israel

Site Status

Western Galilee Hospital; Nrphrology Dept.

Nahariya, , Israel

Site Status

EMMS Nazareth; Nephrology

Nazareth, , Israel

Site Status

Holy Family Hospital; Nephrology

Nazareth, , Israel

Site Status

Beilinson Medical Center; Nephrology

Petah Tikva, , Israel

Site Status

Sheba MC; Nephrology

Ramat Gan, , Israel

Site Status

Rebecca Sief Hospital; Nephrology

Safed, , Israel

Site Status

Sourasky MC; Dept. of Nephrology

Tel Aviv, , Israel

Site Status

Poria Hospital; Nephrology

Tiberias, , Israel

Site Status

Assaf-Harofeh MC; Nephrology

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ML22556

Identifier Type: -

Identifier Source: org_study_id

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