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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00773513




Registration number
NCT00773513
Ethics application status
Date submitted
15/10/2008
Date registered
16/10/2008
Date last updated
20/08/2019

Titles & IDs
Public title
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
Scientific title
A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
Secondary ID [1] 0 0
2007-005129-31
Secondary ID [2] 0 0
BH21260
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Renal Anemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin Alfa
Treatment: Drugs - Epoetin Alfa
Treatment: Drugs - Epoetin Beta
Treatment: Drugs - methoxy polyethylene glycol-epoetin beta

Active Comparator: Erythropoiesis Stimulating Agents - Participants will receive reference ESA according to approved label. The approved reference ESA compounds in the study will be darbepoetin alfa, epoetin alfa and epoetin beta.

Experimental: Methoxy Polyethylene Glycol-Epoetin Beta - Participants not currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta iv or sc once every 2 weeks for correction of renal anemia (target Hb 10-12 g/dL). Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta will be administered once monthly.


Treatment: Drugs: Darbepoetin Alfa
Darbepoetin alfa will be administered as per approved label.

Treatment: Drugs: Epoetin Alfa
Epoetin alfa will be administered as per approved label.

Treatment: Drugs: Epoetin Beta
Epoetin beta will be administered as per approved label.

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta
Participants who are currently not being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta administered at a starting dose of 0.6 mcg/kg body weight once every 2 weeks. Participants who are currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta at a dose of 120, 200 or 360 mcg once monthly (based on ESA dose administered in Week -1)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
Timepoint [1] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [1] 0 0
Time to All-Cause Mortality
Timepoint [1] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [2] 0 0
Time to Non-Fatal and Fatal Myocardial Infarction
Timepoint [2] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [3] 0 0
Time to Non-Fatal and Fatal Stroke
Timepoint [3] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [4] 0 0
Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
Timepoint [4] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [5] 0 0
Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
Timepoint [5] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [6] 0 0
Percentage of Participants With Gastrointestinal Bleeding
Timepoint [6] 0 0
Baseline up to approximately 8.5 years
Secondary outcome [7] 0 0
Percentage of Participants With Thromboembolic Events
Timepoint [7] 0 0
Baseline up to approximately 8.5 years

Eligibility
Key inclusion criteria
- Male or female participants with symptomatic anemia associated with CKD

- Participants with renal anemia who are not treated with an ESA:

- Anemia was defined as hemoglobin (Hb) concentration less than (<) 11.0 grams per
deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2
weeks between measurements) with clinical indication for ESA treatment

- Participants with renal anemia who are on maintenance ESA therapy:

- If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the
same mode of dialysis for at least 3 months before screening

- Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one
day and a maximum of 2 weeks between measurements)

- Participants with adequate iron status defined as: serum ferritin above or equal to
100 micrograms per liter or transferrin saturation above or equal to 20 percent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the
active substance or any of the excipients, any other contraindication to ESA therapy

- Conditions known to cause inadequate response to ESA treatment or anemia other than
symptomatic anemia associated with CKD:

- History of hemoglobinopathy

- Anemia due to hemolysis

- Pure red cell aplasia

- High likelihood of early withdrawal (for example, within 1 year) or interruption of
the study

- Pregnancy or breast-feeding

- Women of childbearing potential without effective contraception

- Administration of another investigational drug within 1 month before screening or
planned during the study period

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital; Renal - Gosford
Recruitment hospital [2] 0 0
Renal Research Dr Simon Roger - Gosford
Recruitment hospital [3] 0 0
Cairns Hospital; Renal Services - Cairns
Recruitment hospital [4] 0 0
Gold Coast Hospital Department of Pharmacology & Therapeutics - Southport
Recruitment hospital [5] 0 0
ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS - Adelaide
Recruitment hospital [6] 0 0
Launceston General Hospital; Diabetes and Renal Research Unit - Launceston
Recruitment hospital [7] 0 0
Monash Medical Centre; Renal Transplant Unit - Clayton
Recruitment hospital [8] 0 0
Royal Perth Hospital; Nephrology - Perth
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3186 - Clayton
Recruitment postcode(s) [7] 0 0
6847 - Perth
Recruitment outside Australia
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Buenos Aires
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm safety study will compare the outcome with respect to a composite endpoint of
all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in
CKD participants either on dialysis or not receiving renal replacement therapy under
treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will
be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene
glycol-epoetin beta at the following doses: for participants not already receiving ESA
treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose
of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants
receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will
be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on
the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta
administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs
in accordance with their prescribed dosing information.
Trial website
https://clinicaltrials.gov/show/NCT00773513
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications