NCT00048035

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2002

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2002

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
11.6 years until next milestone

Results Posted

Study results publicly available

December 20, 2016

Completed
Last Updated

December 20, 2016

Status Verified

October 1, 2016

Enrollment Period

3.3 years

First QC Date

October 24, 2002

Results QC Date

May 3, 2016

Last Update Submit

October 26, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

    Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.

    From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Secondary Outcomes (5)

  • Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen

    From Baseline (Day -28 to Day 1) to EOIT (Week 19)

  • Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths

    Up to Week 126

  • Number of Participants With Marked Laboratory Abnormalities

    Up to Week 126

  • Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis

    From Baseline (Day -28 to Day 1) to Week 126

  • Mean Change in Pulse Rate

    Up to Week 126

Study Arms (6)

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

EXPERIMENTAL

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).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

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

EXPERIMENTAL

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).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

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

EXPERIMENTAL

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).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

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

EXPERIMENTAL

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).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

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

EXPERIMENTAL

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).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

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

EXPERIMENTAL

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).

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

Differing doses and frequencies of iv administration

Cohort 1 (RO0503821 [0.25/150 1x/week])Cohort 2 (RO0503821 [0.25/150 1x/2week])Cohort 3 (RO0503821 [0.4/150 1x/week])Cohort 4 (RO0503821 [0.4/150 1x/2week])Cohort 5 (RO0503821 [0.6/150 1x/week])Cohort 6 (RO0503821 [0.6/150 1x/2week])

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Birmingham, Alabama, 35211, United States

Location

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Louisville, Kentucky, 40202-1718, United States

Location

Unknown Facility

Detroit, Michigan, 48202-2689, United States

Location

Unknown Facility

Detroit, Michigan, 48236, United States

Location

Unknown Facility

Brooklyn Center, Minnesota, 55430, United States

Location

Unknown Facility

Las Vegas, Nevada, 89106, United States

Location

Unknown Facility

Paterson, New Jersey, 07503, United States

Location

Unknown Facility

Brooklyn, New York, 11203, United States

Location

Unknown Facility

Mineola, New York, 11501, United States

Location

Unknown Facility

New York, New York, 10128, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Morgantown, West Virginia, 26506, United States

Location

Related Publications (2)

  • 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.

    PMID: 37651553DERIVED

  • 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.

    PMID: 36791280DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 61 6878333

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
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2002

First Posted

October 25, 2002

Study Start

March 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 20, 2016

Results First Posted

December 20, 2016

Record last verified: 2016-10

Locations

US(14)