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Completed

NCT Number: NCT00717366

Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis

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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Key information

Conditions

Renal Anemia

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Children'S Hospital; Department of Nephrology, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Will be administered IV, every 4 weeks.

Other names: MIRCERA, RO0503821

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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)

    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).

  2. 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)

    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).

  3. Number of Participants With Blood Transfusions

    Time frame: Baseline to Week 20

  4. 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)

    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.

  5. 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

    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.

  6. 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

    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).

  7. 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

    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.

  8. 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

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2008
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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