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Prednisolone Trial in Children Younger Than 4 Years

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141970
Recruitment Status : Active, not recruiting
First Posted : May 5, 2017
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
NephCure Accelerating Cures Institute
University of Michigan
Department of Biotechnology, Government of India (funding agency)
Information provided by (Responsible Party):
Arvind Bagga, All India Institute of Medical Sciences, New Delhi

Brief Summary:
This study is a multicentric, randomized, parallel group, open label controlled trial of children age 1 year up to 4 years with new onset, idiopathic nephrotic syndrome. It is designed to test the initial duration of steroid therapy of either 3 month or 6 month total duration. Participants will be randomized to either extend their pre-trial 3 months (12 weeks) of standard of care corticosteroid therapy to add an additional 12 weeks of therapy or to stop therapy. Pre-trial standard of care corticosteroids will include 60 mg/m2/day for 6 weeks followed by 40 mg/m2/day every other day for 6 weeks of prednisolone or equivalent. The trial intervention will therefore be an additional 12 vs 0 weeks of corticosteroids in these children with idiopathic nephrotic syndrome.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Prednisolone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentric, Parallel group, Open label randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicentric, Open Label, Parallel Group Trial to Compare the Efficacy of 6-months Versus 3-months Therapy With Prednisolone for the First Episode of Idiopathic Nephrotic Syndrome in Children Younger Than 4 Years
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2021


Arm Intervention/treatment
Experimental: Intervention: Prednisolone
Drug: 12- Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone. Post randomization Prednisolone therapy of 30 mg/m2 on alternate days for 4 weeks, 20 mg/m2 on alternate days for 4 weeks, and 10 mg/m2 on alternate days for 4 weeks
Drug: Prednisolone
Prednisolone for 12 weeks as follows 30 mg/m2 on alternate days for 4 weeks 20 mg/m2 on alternate days for 4 weeks 10 mg/m2 on alternate days for 4 weeks
Other Name: Prednisone

No Intervention: No intervention
Subjects will NOT receive 12-weeks of additional Prednisolone therapy following randomization



Primary Outcome Measures :
  1. Relapse of nephrotic syndrome during 12 months after randomization [ Time Frame: 12 month period following randomization ]
    Proportion of patients with one or more relapse(s) of nephrotic syndrome


Secondary Outcome Measures :
  1. Number of relapses during 12 months follow up [ Time Frame: 12 month period following randomization ]
    Number of nephrotic syndrome relapses per patient year during the 12-month period following randomization

  2. Time to first relapse (days) [ Time Frame: 12 month period following randomization ]
    Number of days from randomization to occurrence of first relapse

  3. Occurrence of frequent relapses of nephrotic syndrome during 12 months from randomization [ Time Frame: 12 month period following randomization ]
    Proportion of patients with frequent relapses during the 12 months post randomization

  4. Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period from randomization [ Time Frame: 12 month period following randomization ]
    Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months from randomization

  5. The use of steroid-sparing medications [ Time Frame: 12 month period following randomization ]
    The proportion of patients in each study arm treated with steroid-sparing strategies or medications, e.g., levamisole, cyclophosphamide, mycophenolate mofetil and calcineurin inhibitors

  6. Adverse events during 12-month period after randomization [ Time Frame: 12 month period following randomization ]
    Number and types of adverse events experienced, related or unrelated to corticosteroid use

  7. Change in anthropometry and growth velocity during 12-month period after randomization [ Time Frame: 12 month period following randomization ]
    Changes in standard deviation scores (SDS) for weight, height and body mass index during 12-month period following randomization


Other Outcome Measures:
  1. In a subgroup of 20 patients, the proportions of the following cell subsets, at baseline and at 6 and 12 months after randomization and at first relapse [ Time Frame: 12 month period following randomization ]
    Proportions of B (naive, memory, regulatory) and T (cytotoxic, helper 1, helper 2, helper 17, regulatory) cell subsets, as determined by flow cytometric staining for specific surface and intracellular markers

  2. Relapse of nephrotic syndrome during 24 months after randomization [ Time Frame: 24 month period following randomization ]
    Proportion of patients with one or more relapse(s) of nephrotic syndrome

  3. Number of relapses during 24 months follow up [ Time Frame: 24 month period following randomization ]
    Number of nephrotic syndrome relapses per patient year during the 24-month period

  4. Time to first relapse (days) [ Time Frame: 24 month period following randomization ]
    Number of days from randomization to occurrence of first relapse

  5. Occurrence of frequent relapses of nephrotic syndrome during 24 months from randomization [ Time Frame: 24 month period following randomization ]
    Proportion of patients with frequent relapses during the 24 months post randomization

  6. Cumulative prednisolone [or corticosteroid equivalent] received during 24 month period [ Time Frame: 24 month period following randomization ]
    Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 24 months from randomization

  7. Relapse of nephrotic syndrome during 12 months after randomization in boys compared to girls [ Time Frame: 12 month period following randomization ]
    Proportion of patients with one or more relapse(s) of nephrotic syndrome in boys compared to girls

  8. Relapse of nephrotic syndrome during 12 months after randomization in patients <2-yr-old at randomization compared to older patients [ Time Frame: 12 month period following randomization ]
    Proportion of patients with one or more relapse(s) of nephrotic syndrome in patients <2-yr-old at randomization compared to older patients

  9. Relapse of nephrotic syndrome during 12 months after randomization in Indian patients compared to those in the USA [ Time Frame: 12 month period following randomization ]
    Proportion of patients with one or more relapse(s) of nephrotic syndrome in Indian patients compared to those in the USA

  10. Number of relapses during 12 months follow up in boys compared to girls [ Time Frame: 12 month period following randomization ]
    Number of nephrotic syndrome relapses per patient year during the 12-month period in boys compared to girls

  11. Number of relapses during 12 months follow up in patients <2-yr-old at randomization compared to older patients [ Time Frame: 12 month period following randomization ]
    Number of nephrotic syndrome relapses per patient year during the 12-month period in patients <2-yr-old at randomization compared to older patients

  12. Number of relapses during 12 months follow up in Indian patients compared to those in the USA [ Time Frame: 12 month period following randomization ]
    Number of nephrotic syndrome relapses per patient year during the 12-month period in Indian patients compared to those in the USA

  13. Time to first relapse (days) in boys compared to girls [ Time Frame: 12 month period following randomization ]
    Number of days from randomization to occurrence of first relapse in boys compared to girls

  14. Time to first relapse (days) in patients <2-yr-old at randomization compared to older patients [ Time Frame: 12 month period following randomization ]
    Number of days from randomization to occurrence of first relapse in patients <2-yr-old at randomization compared to older patients

  15. Time to first relapse (days) in Indian patients compared to those in the USA [ Time Frame: 12 month period following randomization ]
    Number of days from randomization to occurrence of first relapse in Indian patients compared to those in the USA

  16. Occurrence of frequent relapses of nephrotic syndrome during 12 months from randomization in boys compared to girls [ Time Frame: 12 month period following randomization ]
    Proportion of patients with frequent relapses during the 12 months post randomization in boys compared to girls

  17. Occurrence of frequent relapses of nephrotic syndrome during 12 months from randomization in patients <2-yr-old at randomization compared to older patients [ Time Frame: 12 month period following randomization ]
    Proportion of patients with frequent relapses during the 12 months post randomization in patients <2-yr-old at randomization compared to older patients

  18. Occurrence of frequent relapses of nephrotic syndrome during 12 months from randomization in Indian patients compared to those in the USA [ Time Frame: 12 month period following randomization ]
    Proportion of patients with frequent relapses during the 12 months post randomization in Indian patients compared to those in the USA

  19. Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period in boys compared to girls [ Time Frame: 12 month period following randomization ]
    Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months from randomization in boys compared to girls

  20. Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period in patients <2-yr-old at randomization compared to older patients [ Time Frame: 12 month period following randomization ]
    Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months from randomization in patients <2-yr-old at randomization compared to older patients

  21. Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period in Indian patients compared to those in the USA [ Time Frame: 12 month period following randomization ]
    Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months from randomization in Indian patients compared to those in the USA



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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
  2. Age 12 months up to 48 months
  3. Written informed consent

Exclusion Criteria

  1. Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.
  2. Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2,
  3. Therapy with prednisolone for prior episodes of nephrotic syndrome,
  4. Therapy with corticosteroids in the past 3 months, in a dose more than 1 mg/kg for >14 days for any other reason,
  5. Corticosteroid therapy for initial episode of nephrotic syndrome prior to randomization varying from pre-specified protocol on more than 14 days,
  6. Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome,
  7. Unclear treatment history,
  8. Gross hematuria,
  9. Patients with initial steroid resistance,
  10. Participation in any other drug study during the course of this study.
  11. Participation in more than one study without approval from the researchers involved in each study,

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): NCT03141970


Locations
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United States, California
Cedars-Sinai Medical Center, Pediatric IBD & Pediatric Nephrology
Los Angeles, California, United States, 90048
Stanford University Medical Center, Department of Pediatrics, Division of Nephrology
Stanford, California, United States, 94305
United States, Michigan
University of Michigan Department of Pedatric Nephrology
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Levine's Children/Carolinas HealthCare System
Charlotte, North Carolina, United States, 28207
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
NephCure Accelerating Cures Institute
University of Michigan
Department of Biotechnology, Government of India (funding agency)
Investigators
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Principal Investigator: Arvind Bagga, MD All India Institute of Medical Sciences, New Delhi, India
Principal Investigator: Debbie Gipson, MD University of Michigan
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: CTRI/2015/06/005939
Contains details of registration of clinical trial prior to recruiting patients in India, at website of Clinical Trials Registry of India

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Responsible Party: Arvind Bagga, Professor, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03141970    
Other Study ID Numbers: v1.0
CTRI/2015/06/005939 ( Registry Identifier: Clinical Trials Registry-India )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following anonymisation to protect patient identity, data from patients in USA will be pooled and analyzed with that from Indian patients. Data will be available once all subjects have completed the study and data has been analyzed. No interim data analysis will be conducted
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arvind Bagga, All India Institute of Medical Sciences, New Delhi:
Proteinuria Hypoproteinemia Edema Hypoalbuminemia Prednisone
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Prednisone
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents