Initial treatment of nephrotic syndrome in childre

Phase 1

• Conditions: Idiopathic nephrotic syndrome in childhood; MedDRA version: 21.1Level: PTClassification code 10029164Term: Nephrotic syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-001991-76-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-30
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for admission to the study:
-First episode of steroid-sensitive nephrotic syndrome (SSNS)
-in remission induced by daily glucocorticoids
-male and female children aged = 1 year and = 10 years at beginning of study (typical age range of patients with SSNS
-Ability of the persons having care and custody of the child to understand character and individual consequences of clinical study
-Written informed consent of the persons having care and custody of the child (must be available before enrolment in the study)

Are the trial subjects under 18? yes
Number of subjects for this age range: 340
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following criteria will not be included in the study:

-Secondary nephrotic syndrome
-estimated glomerular filtration rate (eGFR) <90 ml/min x 1.73 m2 BSA
-Ongoing treatment with systematically administered glucocorticoids or other immunosuppressive drugs at time of first episode of nephrotic syndrome.
• Hemoglobin concentration of =9 g/dL
• Leucocyte count of =2.500/µl
Refusal of subject (please see also chapter 10.5)•
Severe chronic gastrointestinal disease

-History of hypersensitivity to mycophenolate mofetil or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of suspension of mycophenolate mofetil (CellCept suspension?)
-Participation in other clinical studies or observation period of competing studies, respectively.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified