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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Blood 0 0 0 0
Anaemia
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 - 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 - Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before 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 - A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
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 - The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.
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 - Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.
Timepoint [2] 0 0
Baseline up to Week 28
Secondary outcome [3] 0 0
Percentage of Participants With Red Blood Cell (RBC) Transfusions - The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.
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 - Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.
Timepoint [4] 0 0
Baseline to Week 8
Secondary outcome [5] 0 0
Percentage of Participants With Stable Hemoglobin Response - A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.
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 - The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.
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
Gender
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
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)
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
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous
darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who
are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants
will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2
micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45
mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is
3-12 months.
Trial website
https://clinicaltrials.gov/show/NCT00559273
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