Status:
COMPLETED
Rituximab in Multirelapsing Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS)
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
2-80 years
Phase:
PHASE3
Brief Summary
Background. Patients, especially children, with steroid-dependent or multirelapsing nephrotic syndrome (NS) secondary to minimal change disease (MCD) or idiopathic focal and segmental glomeruloscleros...
Detailed Description
BACKGROUND Nephrotic syndrome (NS)affects 2 every 100,000 children younger than 16 years. Minimal change disease (MCD) accounts for around 90 percent of cases and most of the remaining ones are associ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Males and females
- Steroid-dependent or multirelapsing NS (defined on the basis of the occurrence of more than 2 relapses in the previous year in spite of steroid and/or other immunosuppressive therapy). Only patients reported to invariably relapse upon treatment tapering or withdrawal who are on stable (from at least 1 month) complete (\<0.3 g/24h for adults or \<4 mg/h/m2 for children) or partial (\<3.5 g/24h for adults or \<40 mg/h/m2 for children) remission of the NS will be included;
- Histological diagnosis of MCD or FSGS or mesangial proliferative GN;
- Written informed consent (or consent from parents or tutors for underage patients).
- Exclusion criteria:
- Advanced renal failure (creatinine clearance less than 20 ml/min/1.73m2);
- Evidence of B or C virus infection;
- Refractory or persistent NS;
- Genetic mutations associated with intrinsic abnormalities of the glomerular barrier that would hardly be affected by rituximab treatment;
- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form of contraception;
- Legal incapacity;
- Evidence of an uncooperative attitude;
- Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia.
- Any evidence that patient will not be able to complete the trial follow-up.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00981838
Start Date
April 1 2009
End Date
April 1 2011
Last Update
February 25 2013
Active Locations (7)
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1
Hospital "Azienda Ospedaliera Ospedali Riunitidi Bergamo"Unit of Nephrology and Dialysis
Bergamo, Bergamo, Italy, 24100
2
Hospital "Azienda Ospedaliera santobono-Pausilipon" - Unit of Nephrology and Dialysis
Napoli, Napoli, Italy
3
Hospital "Azienda Ospedaliero Universitaria Federico II" - Nephrology
Napoli, Napoli, Italy
4
Hospital "Seconda Università di Napoli" - Policlinico Nuovo
Napoli, Napoli, Italy