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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00717366




Registration number
NCT00717366
Ethics application status
Date submitted
16/07/2008
Date registered
17/07/2008
Date last updated
8/09/2017

Titles & IDs
Public title
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
Scientific title
An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis
Secondary ID [1] 0 0
2007-007758-70
Secondary ID [2] 0 0
NH19707
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methoxy Polyethylene Glycol-Epoetin Beta

Experimental: MIRCERA Group 1: Intermediate-Conversion-Factor Group - Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.

Experimental: MIRCERA Group 2: High-Conversion-Factor Group - Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.


Treatment: Drugs: Methoxy Polyethylene Glycol-Epoetin Beta
Will be administered IV, every 4 weeks.

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

Outcomes
Primary outcome [1] 0 0
Change in Average Hb Concentration Between Baseline and Evaluation Period - A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.
Timepoint [1] 0 0
Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
Secondary outcome [1] 0 0
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb - Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).
Timepoint [1] 0 0
Evaluation Period (Week 17 to Week 21)
Secondary outcome [2] 0 0
Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL - The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).
Timepoint [2] 0 0
Evaluation Period (Week 17 to Week 21)
Secondary outcome [3] 0 0
Number of Participants With Blood Transfusions
Timepoint [3] 0 0
Baseline to Week 20
Secondary outcome [4] 0 0
Change in Average Reticulocyte Count Between the Baseline and Evaluation Period - A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.
Timepoint [4] 0 0
Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
Secondary outcome [5] 0 0
Maximum Observed Serum Concentration (Cmax) of MIRCERA - Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.
Timepoint [5] 0 0
Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
Secondary outcome [6] 0 0
Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA - Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).
Timepoint [6] 0 0
Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
Secondary outcome [7] 0 0
Time to Reach Cmax (Tmax) of MIRCERA - Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.
Timepoint [7] 0 0
Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
Secondary outcome [8] 0 0
Apparent Terminal Phase Half-Life (t1/2) of MIRCERA - t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by ?z; where ?z = terminal elimination rate constant.
Timepoint [8] 0 0
Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

Eligibility
Key inclusion criteria
- Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic
renal anemia

- Hemodialysis for greater than or equal to (>=) 8 weeks

- Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or
darbepoetin alfa for >= 8 weeks before screening and with no weekly dose change >= 25
percent (%) (increase or decrease) during the 2 weeks of screening
Minimum age
5 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Overt gastrointestinal bleeding within 8 weeks before screening or during the
screening period

- Red blood cell (RBC) transfusions within 8 weeks before screening or during the
screening period

- Active malignant disease

- Pure red cell aplasia (PRCA) or history of PRCA

- Pregnant or lactating females

- Sexually active participants: not willing to use reliable contraception during
treatment and for 90 days following the end of treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 2
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)
VIC
Recruitment hospital [1] 0 0
Royal Children'S Hospital; Department of Nephrology - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
France
State/province [3] 0 0
Bron
Country [4] 0 0
France
State/province [4] 0 0
Lille
Country [5] 0 0
France
State/province [5] 0 0
Marseille
Country [6] 0 0
France
State/province [6] 0 0
Montpellier
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Strasbourg
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Germany
State/province [10] 0 0
Heidelberg
Country [11] 0 0
Germany
State/province [11] 0 0
Köln
Country [12] 0 0
Germany
State/province [12] 0 0
Memmingen
Country [13] 0 0
Germany
State/province [13] 0 0
Münster
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Italy
State/province [15] 0 0
Lazio
Country [16] 0 0
Italy
State/province [16] 0 0
Liguria
Country [17] 0 0
Italy
State/province [17] 0 0
Piemonte
Country [18] 0 0
Italy
State/province [18] 0 0
Veneto
Country [19] 0 0
Poland
State/province [19] 0 0
Gdansk
Country [20] 0 0
Poland
State/province [20] 0 0
Lodz
Country [21] 0 0
Poland
State/province [21] 0 0
Lublin
Country [22] 0 0
Poland
State/province [22] 0 0
Szczecin
Country [23] 0 0
Poland
State/province [23] 0 0
Torun
Country [24] 0 0
Poland
State/province [24] 0 0
Warszawa
Country [25] 0 0
Poland
State/province [25] 0 0
Wroclaw
Country [26] 0 0
Romania
State/province [26] 0 0
Bucharest
Country [27] 0 0
Romania
State/province [27] 0 0
Iasi
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saint-Petersburg
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia
Country [34] 0 0
Thailand
State/province [34] 0 0
Bangkok
Country [35] 0 0
Ukraine
State/province [35] 0 0
Kiev
Country [36] 0 0
Ukraine
State/province [36] 0 0
Zaporizhzhia

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

Ethics approval
Ethics application status

Summary
Brief summary
This sequential study will assess the efficacy and safety of multiple doses of intravenous
(IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum
starting dose for maintenance treatment of anemia in children with chronic kidney disease on
hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin
alfa during the screening period, after which they will receive IV MIRCERA monthly, at a
starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on
the response achieved, another group may be selected to receive a higher or a lower dose.
Trial website
https://clinicaltrials.gov/show/NCT00717366
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