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

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

Sponsors

Lead sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
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.

Overall Status Completed
Start Date March 2002
Completion Date November 2004
Primary Completion Date October 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary Outcome
Measure Time Frame
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
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline (Day -28 to Day 1) to Week 125
Enrollment 65
Condition
Intervention

Intervention type: Drug

Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]

Description: Differing doses and frequencies of sc administration

Eligibility

Criteria:

Inclusion Criteria:

- adult patients >=18 years of age;

- chronic renal anemia;

- not receiving renal replacement therapy.

Exclusion Criteria:

- women who are pregnant, breastfeeding or using unreliable birth control methods;

- administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
facility
| Birmingham, Alabama, 35211, United States
| San Diego, California, 92103-8342, United States
| Detroit, Michigan, 48202-2689, United States
| Detroit, Michigan, 48236, United States
| Las Vegas, Nevada, 89106, United States
| Portland, Oregon, 97201-2940, United States
| Edmonton, Alberta, T6G 2B7, Canada
| Vancouver, British Columbia, V6Z 1Y6, Canada
| Mexico City, 14000, Mexico
| Monterrey, 64710, Mexico
| Gdansk, 80-211, Poland
| Krakow, 31-501, Poland
| Wroclaw, 50-417, Poland
| Belfast, BT9 7LJ, United Kingdom
| London, SE22 8PT, United Kingdom
Location Countries

Canada

Mexico

Poland

United Kingdom

United States

Verification Date

May 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 9
Arm Group

Arm group label: Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)

Arm group type: Experimental

Description: 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.

Arm group label: Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). 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.

Arm group label: Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). 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.

Arm group label: Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two 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.

Arm group label: Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). 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.

Arm group label: Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). 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.

Arm group label: Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three 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.

Arm group label: Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). 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.

Arm group label: Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)

Arm group type: Experimental

Description: Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov