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A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

NCT ID: NCT00048035

Last Updated: 2016-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-06-30

Brief Summary

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This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 (RO0503821 [0.25/150 1x/week])

Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

Differing doses and frequencies of iv administration

Cohort 2 (RO0503821 [0.25/150 1x/2week])

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

Differing doses and frequencies of iv administration

Cohort 3 (RO0503821 [0.4/150 1x/week])

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

Differing doses and frequencies of iv administration

Cohort 4 (RO0503821 [0.4/150 1x/2week])

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

Differing doses and frequencies of iv administration

Cohort 5 (RO0503821 [0.6/150 1x/week])

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

Differing doses and frequencies of iv administration

Cohort 6 (RO0503821 [0.6/150 1x/2week])

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

Differing doses and frequencies of iv administration

Interventions

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methoxy polyethylene glycol-epoetin beta [Mircera]

Differing doses and frequencies of iv administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients \>=18 years of age;
* chronic renal anemia;
* on hemodialysis therapy for at least 3 months;
* receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment 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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Birmingham, Alabama, United States

Site Status

Los Angeles, California, United States

Site Status

Maywood, Illinois, United States

Site Status

Louisville, Kentucky, United States

Site Status

Detroit, Michigan, United States

Site Status

Detroit, Michigan, United States

Site Status

Brooklyn Center, Minnesota, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Paterson, New Jersey, United States

Site Status

Brooklyn, New York, United States

Site Status

Mineola, New York, United States

Site Status

New York, New York, United States

Site Status

Nashville, Tennessee, United States

Site Status

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

Reference Type DERIVED
PMID: 37651553 (View on PubMed)

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type DERIVED
PMID: 36791280 (View on PubMed)

Other Identifiers

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BA16285

Identifier Type: -

Identifier Source: org_study_id