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Renal AnemiaPhase 2NCT00717366

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

A Phase 2 study testing Methoxy Polyethylene Glycol-Epoetin Beta in people with Renal Anemia, run by Hoffmann-La Roche at 39 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Renal Anemia
What is being tested?
Methoxy Polyethylene Glycol-Epoetin Beta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
39 sitesin 12 countries
Study dates
Jul 2008to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 12 countries.

39 sites in 12 countries

France7 sites

  • Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

    Bron, 69677

  • Hopital Jeanne De Flandre; Cons Pediatrie

    Lille, 59037

  • Hopital Timone Enfants; Nephrologie Hemodialyse

    Marseille, 13385

  • Hopital Arnaud De Villeneuve; Pediatrie I

    Montpellier, 34295

  • Hôpital Robert Debré; Nephrologie pediatrique

    Paris, 75019

  • Hopital Armand Trousseau; Pediatrie Nephrologie

    Paris, 75571

  • Höpital Hautepierre; Pediatrie 1

    Strasbourg, 67098

Other trials in France

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

    Gdansk, 80-294

  • Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii

    Lodz, 93-338

  • Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej

    Lublin, 20-093

  • SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ

    Szczecin, 70-410

  • Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii

    Torun, 87-100

  • Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

    Warsaw, 04-730

  • Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej

    Wroclaw, 50-369

Other trials in Poland

Germany5 sites

  • Klinik der Uni zu Köln; Kinderklinik

    Cologne, 50937

  • KfH Nierenzentrum für Kinder und Jugendliche

    Hamburg, 20246

  • KfH-Nierenzentrum fur Kinder und Jugendliche

    Heidelberg, 69120

  • Kinderklinik Memmingen; Kinderdialysezentrum

    Memmingen, 87700

  • KfH-Nierenzentrum für Kinder und Jugendliche

    Münster, 48149

Other trials in Germany

Italy4 sites

  • IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

    Genoa, Liguria, 16148

  • A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto

    Padova, Veneto, 35128

  • Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

    Rome, Lazio, 00165

  • Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

    Turin, Piedmont, 10126

Other trials in Italy

Spain4 sites

  • Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

    Barcelona, 08035

  • Hospital Universitario La Paz: Nefrologia Pediatrica

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

    Seville, 41013

  • Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica

    Valencia, 46009

Other trials in Spain

Belgium2 sites

  • Hôpital Enfants Reine Fabiola

    Brussels, 1020

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Romania2 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • St. Maria Emergency Clinical Hospital for Children

    Iași, 700309

Other trials in Romania

Russia2 sites

  • DGCB St. Vladimir; Pediatric nephrologist

    Moscow, 107014

  • SBIH Children City Hospital #1; Dialysis department

    Saint Petersburg, 198205

Other trials in Russia

Thailand2 sites

  • Chulalongkorn university Faculty of Medicine;Department of Pediatrics

    Bangkok, 10310

  • Siriraj Hospital, Faculty of Medicine; Department of Pediatrics

    Bangkok, 10700

Other trials in Thailand

Ukraine2 sites

  • Kiev city childrens nephrological center of hospital #1; Nephrology and RRT

    Kiev, 04209

  • Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic

    Zaporizhzhya, 69076

Other trials in Ukraine

Australia1 site

  • Royal Children'S Hospital; Department of Nephrology

    Parkville, Victoria, 3052

Other trials in Australia

Hungary1 site

  • Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

    Budapest, 1083

Other trials in Hungary

About this study

Official 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

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.

Conditions
Renal Anemia
Being tested
Methoxy Polyethylene Glycol-Epoetin Beta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methoxy Polyethylene Glycol-Epoetin BetaDrug

    Also called MIRCERA, RO0503821

    Will be administered IV, every 4 weeks.

Study groups in NCT00717366
Study groupRoleWhat they receive
MIRCERA Group 1: Intermediate-Conversion-Factor GroupExperimentalParticipants 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.
Receives: Drug: Methoxy Polyethylene Glycol-Epoetin Beta
MIRCERA Group 2: High-Conversion-Factor GroupExperimentalParticipants 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.
Receives: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

Secondary outcomes (8)

  1. 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).

    Measured: 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

    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).

    Measured: Evaluation Period (Week 17 to Week 21)

  3. Number of Participants With Blood Transfusions

    Measured: Baseline to Week 20

  4. 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.

    Measured: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

  5. 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.

    Measured: 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

  6. 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).

    Measured: 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

  7. 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.

    Measured: 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

  8. 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 λz; where λz = terminal elimination rate constant.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00717366
Sponsor's protocol ID
NH19707
Other IDs
2007-007758-70
Status last verified
Aug 2017
First submitted
16 Jul 2008
Last updated
8 Sep 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methoxy Polyethylene Glycol-Epoetin Beta in people with Renal Anemia, run by Hoffmann-La Roche at 39 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France, Poland, Germany, Italy, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00717366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.

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