NCT00048048|CompletedPhase 2Results

A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy

Hoffmann-La Roche ClinicalTrials.gov

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1 other identifier

BA16528

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredOct 2002

StartedMar 2002

CompletionNov 2004

Brief Summary

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Mar 2002

Geographic Reach

5 countries

15 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

2.7 years study duration

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

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed

13.2 years until next milestone

Results Posted

Study results publicly available

January 2, 2018

Completed

Last Updated

January 2, 2018

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

October 24, 2002

Results QC Date

October 26, 2016

Last Update Submit

May 29, 2017

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Secondary Outcomes (6)

Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen
From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen
From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Number of Participants With Any Serious Adverse Events and Any Adverse Events
Up to Week 125
Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time
Up to Week 125
Heart Rate Over Time
Up to Week 125
+1 more secondary outcomes

Study Arms (9)

Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)

EXPERIMENTAL

Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.