Study comparing outcomes in patients with autoimmune hemolytic uremic syndrome, a severe kidney disease, between patients receiving maintenance therapy with mycophenolate mofetil for one year versus two years
Phase 4
- Conditions
- Health Condition 1: D593- Hemolytic-uremic syndrome
- Registration Number
- CTRI/2024/04/065275
- Lead Sponsor
- AIIMS, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age 3-18 years
2. Diagnosed with anti-FH associated HUS
3. Managed for anti-FH associated HUS for 18-months using the conventional combination of plasma exchanges and immunosuppression as detailed in protocol, including therapy with MMF at 500-750 mg/m2 for 1-yr
Exclusion Criteria
1. One or more relapses of HUS during the 18-months of follow up
2. Current anti-FH antibody titer of less than 1300 AU/mL
3. Infection-associated HUS
4. Secondary HUS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of relapse, defined as recurrence of hematological activity (fall in hemoglobin by 1 g/dl with schistocytes more than 2 percent, LDH more than 450 U/L and/or platelet count less than 100,000/mm3)Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method Anti-FH titerTimepoint: 6 months; 1 year;CKD stages 4-5 (eGFR less than 30 ml/min/1.73 m2)Timepoint: 6 months; 1 year;Estimated GFRTimepoint: 6 months; 1 year;HypertensionTimepoint: 6 months; 1 year;Proteinuria (urine protein/creatinine more than 1 mg/mg)Timepoint: 6 months; 1 year