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Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

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ClinicalTrials.gov Identifier: NCT04536181
Recruitment Status : Withdrawn (lack of funding)
First Posted : September 2, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Brief Summary:
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.

Condition or disease Intervention/treatment Phase
Steroid-Sensitive Nephrotic Syndrome Drug: Prednisolone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome:a Randomized, Double-blind, Placebo-controlled Study
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022


Arm Intervention/treatment
Placebo Comparator: 3 months group
Subjects will receive 12-weeks of placebo following randomization
Drug: Placebo
12 weeks simulated tablets

Experimental: 6 months group
12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone.
Drug: Prednisolone
12 weeks prednisolone treatment
Other Name: prednisone




Primary Outcome Measures :
  1. Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment [ Time Frame: 12 month period after 3 month standard treatment ]
    Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment.


Secondary Outcome Measures :
  1. Number of relapses during 12 months follow up after 3 month standard treatment [ Time Frame: 12 month period after 3 month standard treatment ]
    Number of nephrotic syndrome relapses per patient year during the 12-month period after 3 month standard treatment

  2. Time to first relapse (days) [ Time Frame: 12 month period after 3 month standard treatment ]
    Number of days from randomization to occurrence of first relapse

  3. Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment [ Time Frame: 12 month period after 3 month standard treatment ]
    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 follow up after 3 month standard treatment

  4. The use of steroid-sparing medications [ Time Frame: 12 month period after 3 month standard treatment ]
    The proportion of patients in each study arm treated with steroid-sparing strategies or medications.it is a binary varibale (1/0). The variable wolud be sette into "1", if the patients use the steroid-sparing medications such as cyclophosphamide, levamisole, mycophenolate mofetil,rituximab and so on.

  5. Adverse events during 12-month period after 3 month standard treatment [ Time Frame: 12 month period after 3 month standard treatment ]
    Number of adverse events experienced, related or unrelated to corticosteroid use

  6. Change in height during 12-month period after 3 month standard treatment [ Time Frame: 12 month period after 3 month standard treatment ]
    The standard deviation scores (SDS) for height will be measured at 12th month and randomization. Change in height is SDS at 12 month minus that of randomization.

  7. Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment [ Time Frame: 12 month period after 3 month standard treatment ]
    Proportion of patients with steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment.Steroid-dependent nephrotic syndrome was defined as steroid-sensitive nephrotic syndrome with 2 or more consecutive relapses during tapering or within 14 days of stopping steroids.



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
  • Age 12 months up to 6 years
  • Written informed consent

Exclusion Criteria:

  • 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.
  • Therapy with prednisolone for prior episodes of nephrotic syndrome
  • Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2
  • Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
  • Patients with initial steroid resistance
  • Patients who are allergic to glucocorticoids
  • The compliance of patients or their guardians is poor

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): NCT04536181


Locations
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China, Shanghai
Children's hospital of Fudan university
Shanghai, Shanghai, China, 200000
China
Shanghai Children's Hospital
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Principal Investigator: Hong Xu, PhD.MD. Children's Hospital of Fudan University
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04536181    
Other Study ID Numbers: CSICS
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Hypersensitivity
Syndrome
Disease
Pathologic Processes
Immune System Diseases
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