TriangleNCT00717366 · CITED IN SOURCE DOCUMENTS
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-09-08
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.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Change in Average Hb Concentration Between Baseline and Evaluation Period
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb
Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
Number of Participants With Blood Transfusions
Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
Maximum Observed Serum Concentration (Cmax) of MIRCERA
Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA
Time to Reach Cmax (Tmax) of MIRCERA
Apparent Terminal Phase Half-Life (t1/2) of MIRCERA
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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 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
- healthy Volunteers
- false
- maximum Age
- 17 Years
- minimum Age
- 5 Years
- sex
- ALL
- std Ages
- CHILD
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Methoxy Polyethylene Glycol-Epoetin Beta
- label
- MIRCERA Group 1: Intermediate-Conversion-Factor Group
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Drug: Methoxy Polyethylene Glycol-Epoetin Beta
- label
- MIRCERA Group 2: High-Conversion-Factor Group
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- MIRCERA Group 1: Intermediate-Conversion-Factor Group
- MIRCERA Group 2: High-Conversion-Factor Group
- description
- Will be administered IV, every 4 weeks.
- name
- Methoxy Polyethylene Glycol-Epoetin Beta
- other Names
- MIRCERA
- RO0503821
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 64
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Change in Average Hb Concentration Between Baseline and Evaluation Period
- time Frame
- Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
- secondary Outcomes
- description
- 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).
- measure
- Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb
- time Frame
- Evaluation Period (Week 17 to Week 21)
- description
- 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).
- measure
- Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL
- time Frame
- Evaluation Period (Week 17 to Week 21)
- measure
- Number of Participants With Blood Transfusions
- time Frame
- Baseline to Week 20
- description
- 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.
- measure
- Change in Average Reticulocyte Count Between the Baseline and Evaluation Period
- time Frame
- Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
- description
- 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.
- measure
- Maximum Observed Serum Concentration (Cmax) of MIRCERA
- time Frame
- 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
- description
- 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).
- measure
- Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA
- time Frame
- 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
- description
- 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.
- measure
- Time to Reach Cmax (Tmax) of MIRCERA
- time Frame
- 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
- description
- 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 λz; where λz = terminal elimination rate constant.
- measure
- Apparent Terminal Phase Half-Life (t1/2) of MIRCERA
- time Frame
- 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
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- and during treatment. Antibody development was not detected in any of the patients. ELISA testing was conducted in 104 pediatric patients. In the first study (NCT00717366), blood samples to measure anti-Mircera and anti-EPO antibodies were collected on Week 1, Week 13, Week 21 and Week 73. In the second study (NCT03552393), they
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- usly/ subcutaneously (n=168) 11.9 11.9 n/a 14.2 Pediatric Patients Currently Treated with an ESA An open-label, multiple dose, multicenter, dose-finding study (NCT00717366) was conducted to determine the dose of intravenous Mircera when converting from treatment with another ESA (epoetin alfa/beta or darbepoetin alfa). The study
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Preserved source evidence · Not medical advice