Clinical Trial: Prednisolone Trial in Children Younger Than 4 Years

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Child

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.

Detailed Summary:

Trial Registration Note:This trial was initially registered in the Indian Registry (list the number) on (date) prior to enrolling participants. The present listing shows this status of currently enrolling. New sites in the United States are expected to open within the coming year. At that time the answers to some questions, such as "Studies FDA regulated drug" will change because the basis for FDA regulation will reside on the presence of US sites and the use of US manufactured drug, whereas at this time the drug is not of US manufacture, and the trial is not currently conducted in the United States. This registration is being posted at this time to prepare to meet United States FDAAAA registration requirements.

Nephrotic syndrome is a common renal disorder in children characterized by proteinuria, hypoalbuminemia and edema. The long-term prognosis for steroid-sensitive nephrotic syndrome is excellent for resolution of disease and maintenance of renal function. About 80% patients with steroid-sensitive nephrotic syndrome will relapse one or more times, requiring repeated treatment with corticosteroids. Of these, 50-60% show frequent relapses or steroid dependence and require therapy with long-term corticosteroids and other medications. Patients with multiple relapses are at risk for life-threatening infections, malnutrition and thrombotic episodes. They are also likely to show serious side effects of long-term steroid therapy and those related to use of other medications, including toxicity to bone marrow, gonads, central nervous system and kidneys. Repeated relapses also result in multiple hospitalizations and school absence. Strategies effective in reducing relapse rates and proportion of patients with frequent relapses or steroid dependence shall therefore be extremely valuable in improving the long-term management of nephrotic syndrome.

Proportion of patients with one or more relapse(s) of nephrotic syndrome



Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: March 17, 2017
Date Started: July 1, 2015
Date Completion: March 31, 2022
Last Updated: May 3, 2017
Last Verified: May 2017