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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00559273




Registration number
NCT00559273
Ethics application status
Date submitted
15/11/2007
Date registered
16/11/2007
Date last updated
1/11/2016

Titles & IDs
Public title
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Scientific title
An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis
Secondary ID [1] 0 0
NH20052
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Anemia, Chronic 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
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methoxy polyethylene glycol-epoetin beta
Treatment: Drugs - Darbepoetin alfa

Experimental: Mircera - Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.

Active comparator: Darbepoetin Alfa - Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.


Treatment: Drugs: Methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg SC monthly, starting dose

Treatment: Drugs: Darbepoetin alfa
0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Hemoglobin (Hb) Response
Timepoint [1] 0 0
Baseline up to Week 28
Primary outcome [2] 0 0
Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
Timepoint [2] 0 0
Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
Secondary outcome [1] 0 0
Hemoglobin (Hb) Concentration Over the Time
Timepoint [1] 0 0
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)
Secondary outcome [2] 0 0
Time to Hemoglobin Response
Timepoint [2] 0 0
Baseline up to Week 28
Secondary outcome [3] 0 0
Percentage of Participants With Red Blood Cell (RBC) Transfusions
Timepoint [3] 0 0
Baseline up to Week 28
Secondary outcome [4] 0 0
Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL
Timepoint [4] 0 0
Baseline to Week 8
Secondary outcome [5] 0 0
Percentage of Participants With Stable Hemoglobin Response
Timepoint [5] 0 0
Baseline to Week 28
Secondary outcome [6] 0 0
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
Timepoint [6] 0 0
Baseline to Week 28

Eligibility
Key inclusion criteria
* Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance [CrCl]/ glomerular filtration rate [GFR] 30 to 59 milliliter per minutes per 1.73 meter square [mL/min/1.73m^2]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation
* Anemia defined as baseline Hb concentration less than (<) 10.5 gram per deciliter (g/dL)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous therapy with any ESA within 12 weeks prior to screening
* Renal allograft in place
* Immunosuppressive therapy in the 12 weeks prior to screening
* Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening

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 3
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
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
307
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Gosford
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Reservoir
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
3186 - Clayton
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
3073 - Reservoir
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Roeselare
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
France
State/province [6] 0 0
Cahors
Country [7] 0 0
France
State/province [7] 0 0
Clermont-ferrand
Country [8] 0 0
France
State/province [8] 0 0
Limoges
Country [9] 0 0
France
State/province [9] 0 0
Lyon
Country [10] 0 0
France
State/province [10] 0 0
Nice
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Bonn
Country [14] 0 0
Germany
State/province [14] 0 0
Heilbronn
Country [15] 0 0
Germany
State/province [15] 0 0
Homburg/saar
Country [16] 0 0
Greece
State/province [16] 0 0
Alexandroupolis
Country [17] 0 0
Greece
State/province [17] 0 0
Larissa
Country [18] 0 0
Greece
State/province [18] 0 0
Thessaloniki
Country [19] 0 0
Greece
State/province [19] 0 0
Volos
Country [20] 0 0
Hong Kong
State/province [20] 0 0
Hong Kong
Country [21] 0 0
Hungary
State/province [21] 0 0
Baja
Country [22] 0 0
Hungary
State/province [22] 0 0
Budapest
Country [23] 0 0
Hungary
State/province [23] 0 0
Esztergom
Country [24] 0 0
Hungary
State/province [24] 0 0
Hatvan
Country [25] 0 0
Hungary
State/province [25] 0 0
Szigetvar
Country [26] 0 0
Israel
State/province [26] 0 0
Haifa
Country [27] 0 0
Israel
State/province [27] 0 0
Kfar Saba
Country [28] 0 0
Israel
State/province [28] 0 0
Petach Tikva
Country [29] 0 0
Italy
State/province [29] 0 0
Como
Country [30] 0 0
Italy
State/province [30] 0 0
Lecco
Country [31] 0 0
Italy
State/province [31] 0 0
Lodi
Country [32] 0 0
Italy
State/province [32] 0 0
Mestre
Country [33] 0 0
Italy
State/province [33] 0 0
Modena
Country [34] 0 0
Italy
State/province [34] 0 0
Pavia
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Poland
State/province [36] 0 0
Gdansk
Country [37] 0 0
Poland
State/province [37] 0 0
Katowice
Country [38] 0 0
Poland
State/province [38] 0 0
Krakow
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Poland
State/province [40] 0 0
Radom
Country [41] 0 0
Poland
State/province [41] 0 0
Rzeszow
Country [42] 0 0
Poland
State/province [42] 0 0
Sieradz
Country [43] 0 0
Poland
State/province [43] 0 0
Szczecin
Country [44] 0 0
Poland
State/province [44] 0 0
Warszawa
Country [45] 0 0
Poland
State/province [45] 0 0
Wroclaw
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Saratov
Country [48] 0 0
Russian Federation
State/province [48] 0 0
St Petersburg
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Palma de Mallorca
Country [52] 0 0
Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taichung
Country [55] 0 0
Taiwan
State/province [55] 0 0
Taipei
Country [56] 0 0
Thailand
State/province [56] 0 0
Bangkok
Country [57] 0 0
Thailand
State/province [57] 0 0
Nakhon Ratchasima
Country [58] 0 0
Thailand
State/province [58] 0 0
Pathumthani

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00559273