NL-OMON47536
Recruiting
Not Applicable
Double-blind, randomized, placebo controlled study to REduce STEroids in Relapsing Nephrotic syndrome - RESTERN Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age over 1 and less than 18 years;
- •\- Steroid sensitive nephrotic syndrome;
- •\- The last prednisolone use (at a dose over 10 mg/m2 on alternate days) for the
- •treatment of a previous episode was at least 4 weeks ago;
- •\- Signed informed consent from the parent or legal assent and/or the patient, depending on the age of the patient.
Exclusion Criteria
- •\- Steroid resistant nephrotic syndrome;
- •\- Daily prednisone maintenance therapy at any dose;
- •\- Alternate day prednisone maintenance therapy at a dose over 4 mg/m2;
- •\- Documented or suspected significant non\-compliance.
- •\- Pregnancy;
- •\- Stimulant drug use;
- •\- Comorbidity;
- •o Kidney transplant recipient
- •o Any disease that requires the variation in oral prednisolone to be at the
- •discretion of the treating physician(s);
Outcomes
Primary Outcomes
Not specified
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