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

August 8, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children'S Hospital; Department of Nephrology
  • Belgium
      • Bruxelles, Belgium, 1020
        • Hôpital Enfants Reine Fabiola
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • France
      • Bron, France, 69677
        • Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie
      • Lille, France, 59037
        • Hopital Jeanne De Flandre; Cons Pediatrie
      • Marseille, France, 13385
        • Hopital Timone Enfants; Nephrologie Hemodialyse
      • Montpellier, France, 34295
        • Hopital Arnaud De Villeneuve; Pediatrie I
      • Paris, France, 75019
        • Hôpital Robert Debré; Nephrologie pediatrique
      • Paris, France, 75571
        • Hopital Armand Trousseau; Pediatrie Nephrologie
      • Strasbourg, France, 67098
        • Höpital Hautepierre; Pediatrie 1
  • Germany
      • Hamburg, Germany, 20246
        • KfH Nierenzentrum für Kinder und Jugendliche
      • Heidelberg, Germany, 69120
        • KfH-Nierenzentrum für Kinder und Jugendliche
      • Köln, Germany, 50937
        • Klinik der Uni zu Köln; Kinderklinik
      • Memmingen, Germany, 87700
        • Kinderklinik Memmingen; Kinderdialysezentrum
      • Münster, Germany, 48149
        • KfH-Nierenzentrum für Kinder und Jugendliche
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00165
        • Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi
    • Liguria
      • Genova, Liguria, Italy, 16148
        • IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto
    • Veneto
      • Padova, Veneto, Italy, 35128
        • A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto
  • Poland
      • Gdansk, Poland, 80-294
        • Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy
      • Lodz, Poland, 93-338
        • Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii
      • Lublin, Poland, 20-093
        • Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej
      • Szczecin, Poland, 70-410
        • SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii
      • Warszawa, Poland, 04-730
        • Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego
      • Wroclaw, Poland, 50-369
        • Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej
  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute
      • Iasi, Romania, 700309
        • St. Maria Emergency Clinical Hospital for Children
  • Russian Federation
      • Moscow, Russian Federation, 107014
        • DGCB St. Vladimir; Pediatric nephrologist
      • Saint-Petersburg, Russian Federation, 198205
        • SBIH Children City Hospital #1; Dialysis department
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz: Nefrologia Pediatrica
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
      • Valencia, Spain, 46009
        • Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica
  • Thailand
      • Bangkok, Thailand, 10310
        • Chulalongkorn university Faculty of Medicine;Department of Pediatrics
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Faculty of Medicine; Department of Pediatrics
  • Ukraine
      • Kiev, Ukraine, 04209
        • Kiev city childrens nephrological center of hospital #1; Nephrology and RRT
      • Zaporizhzhia, Ukraine, 69076
        • Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Will be administered IV, every 4 weeks.
Other Names:
  • MIRCERA
  • RO0503821
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.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Will be administered IV, every 4 weeks.
Other Names:
  • MIRCERA
  • RO0503821

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Evaluation Period (Week 17 to Week 21)
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).
Evaluation Period (Week 17 to Week 21)
Number of Participants With Blood Transfusions
Time Frame: Baseline to Week 20
Baseline to Week 20
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.
Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
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.
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-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).
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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NH19707
  • 2007-007758-70 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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