Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552393
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

Condition or disease Intervention/treatment Phase
Anemia Renal Insufficiency, Chronic Drug: Mircera Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Multicenter Sudy to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mircera
Mircera will be administered subcutaneously once every 4 weeks
Drug: Mircera
The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.
Other Name: Methoxy polyethylene glycol-epoetin beta




Primary Outcome Measures :
  1. Change From Baseline in Haemoglobin (Hb) Concentration (Gram per Decilitre [g/dL]) [ Time Frame: up to Week 21 ]
    Change in Hb concentration (g/dL) between the baseline and the evaluation period for each patient


Secondary Outcome Measures :
  1. Number of patients with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb or above, within or below the range of 10−12 g/dL [ Time Frame: Week 17 up to Week 21 ]
    Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb or above, within or below the range of 10−12 g/dL.

  2. Change in Mircera dose over time, including the change between the starting dose and the evaluation period [ Time Frame: Week 1 to Week 17 ]
    Change between the starting dose and the evaluation period will be reported.

  3. Number of Participants With Adverse Events by Severity [ Time Frame: Up to Week 45 ]
    An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test.

  4. Change From Baseline in Blood Pressure [ Time Frame: Up to Week 45 ]
    Change in systolic and diastolic blood pressure will be evaluated and reported.

  5. Change From Baseline in Pulse Rate [ Time Frame: Up to Week 45 ]
    Change in pulse rate will be evaluated and reported.

  6. Change from baseline in targeted clinical laboratory test results [ Time Frame: Screening up to Week 45 ]
    Targeted clinical laboratory results will includes hematology, aspartate transaminase (AST), alanine transaminase (ALT), C-reactive protein, potassium, phosphorus, calcium, platelets, serum creatinine and iron parameters.

  7. Area Under the Concentration-Time Curve (AUC) of Mircera [ Time Frame: Pre-dose at Week 1, 9, 17; post-dose at Week 3 and Week 19 and additional sample will be taken between 24 hours and 5 Days at patient's convenience ]
  8. Maximum Plasma Concentration (Cmax) of Mircera [ Time Frame: Pre-dose at Week 1, 9, 17; post-dose at Week 3 and Week 19 and additional sample will be taken between 24 hours and 5 Days at patient's convenience ]
  9. Terminal Elimination Half-Life (t1/2) of Mircera [ Time Frame: Pre-dose at Week 1, 9, 17; Post-dose at Week 3 and Week 19 and additional sample will be taken between 24 hours and 5 Days at patient's convenience ]
  10. Time to Reach the Maximum Plasma Concentration (Tmax) of Mircera [ Time Frame: Pre-dose at Week 1, 9, 17; post-dose at Week 3 and Week 19 and additional sample will be taken between 24 hours and 5 Days at patient's convenience ]
  11. Bioavailability of Mircera [ Time Frame: Pre-dose at Week 1, 9, 17; post-dose at Week 3 and Week 19 and additional sample will be taken between 24 hours and 5 Days at patient's convenience ]
    Bioavailability is defined as the rate and extent to which the administered drug reaches the systemic circulation.

  12. Pharmacodynamic: Serum Concentration of Hb [ Time Frame: Pre-dose at Week 1, 9, 17; post-dose at Week 3 and Week 19 and additional sample will be taken between 24 hours and 5 Days at patient's convenience ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric participants 3 months to 17 years of age with clinically stable chronic renal anemia
  • CKD with estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 (determined by the Bedside Schwartz formula) or dialysis treatment for at least 8 weeks before the first dose of Mircera
  • For participants on peritoneal dialysis (PD): a weekly Kt/V≥ 1.8
  • For participants on HD: adequate HD, urea reduction ratio (URR) > 65% or Kt/V > 1.2 for participants on HD three times per week.

Participants with fewer than or more than three HD sessions per week should have a weekly Kt/V≥ 3.6.

  • Baseline Hb concentration 10.0-12.0 g/dL determined from the mean of two Hb values measured at Visit 1 (Week -3) and Visit 2 (Week -1)
  • Stable SC maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa with the same dosing interval for at least 6 weeks before the first dose of Mircera
  • Stable dose of epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change > 25% (increase or decrease) for at least 4 weeks before the first dose of Mircera
  • Adequate iron status defined as ferritin≥100 ng/mL or transferrin saturation (TSAT)≥ 20% (or percentage of hypochromic red cells < 10%); mean of two values measured during screening.

Exclusion Criteria:

  • Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
  • RBC transfusions within 8 weeks before screening or during the screening period
  • Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) Hemolytic anemia, Active malignant disease
  • PD subjects with an episode of peritonitis within the past 30 days prior to screening and/or during the screening period
  • Uncontrolled or symptomatic inflammatory disease (e.g., systemic lupus erythematosus)
  • Uncontrolled hypertension as assessed by the investigator
  • Epileptic seizures within 3 months prior to screening and during the screening period
  • Administration of any investigational drug within 4 weeks prior to screening or planned during the study
  • Severe hyperparathyroidism (intact parathyroid hormone [PTH]≥ 1000 pg/mL or whole PTH≥ 500 pg/mL) or biopsy-proven bone marrow fibrosis
  • Kidney transplant with use of immunosuppressive therapies known to exacerbate anemia
  • Known hypersensitivity to recombinant human erythropoietin (EPO), polyethylene glycol, or any constituent of the study drug formulation
  • Anti-EPO antibody (AEAB)-mediated pure red cell aplasia (PRCA) or history of AEAB mediated PRCA or positive AEAB test result in the absence of PRCA
  • High likelihood of early withdrawal or interruption of the study (e.g., planned living donor kidney transplant within 5 months of study start)
  • Planned elective surgery during the entire study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552393


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: NH19708 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 32 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03552393     History of Changes
Other Study ID Numbers: NH19708
2016-004779-39 ( EudraCT Number )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Anemia
Hematologic Diseases
Urologic Diseases