Status:
COMPLETED
Reduce Immunosuppression With Atmp in NS ChildrEn
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsors:
Cell Factory Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Laboratorio Sperimentale di Immunologia e Trapianti, Oncoematologia Pediatrica, Fondazione IRCCS Policlinico S. Matteo, Pavia
Conditions:
Nephrotic Syndrome in Children
Steroid-Dependent Nephrotic Syndrome
Eligibility:
All Genders
3-18 years
Phase:
PHASE2
Brief Summary
A phase II open-label, single arm study aimed to ascertain whether infusions of cord-blood mesenchymal stromal cells (CB-MSCs) allow to reduce or suspend the chronic immunosuppressive therapy (IS) in ...
Detailed Description
Background: Nephrotic Syndrome (NS) is a rare disease characterized by nephrotic-range proteinuria and the need for steroid treatment. About 50% of children will become frequent relapsers (FRNS) or s...
Eligibility Criteria
Inclusion
- Age between 3 and 18 years;
- Clinical diagnosis of SDNS;
- Disease remission maintained by chronic therapy (at least 6 months) with either:
- Use of a combination of 2 or more immunosuppressive drugs
- use of 1 of the calcineurin inhibitors (Cyclosporin or Tacrolimus);
- Absence of proteinuria (PrU/CrU \< 0.2 mg/mg) for at least 1 month;
- eGFR greater than or equal to 70 ml/min/1.73 m\^2;
- Written informed consent from parents or guardians and the child when possible
Exclusion
- Age \< 3 years or \> 19 years;
- Resistant/refractory NS;
- Presence of genetic mutations associated with NS;
- eGFR less than 70 ml/min/1.73m2;
- Thrombophilic condition;
- Pregnancy or lactating;
- Evidence of an uncooperative attitude;
- Any evidence that the patient will be unable to complete the trial follow-up.
Key Trial Info
Start Date :
November 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04034316
Start Date
November 2 2018
End Date
August 31 2023
Last Update
September 28 2023
Active Locations (1)
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1
Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
Milan, MI, Italy