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

To examine the non-inferiority of an abbreviated immunosuppression protocol for patients with anti-FH antibody associated HUS - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065275

Enrollment

Registered

2024-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D593- Hemolytic-uremic syndrome

Interventions

Intervention1: Mycophenolate mofetil (MMF): This shall be administered at a dose of 600-800 mg/m2 /day for one year (intervention) in a prospective cohort Control Intervention1: Mycophenolate mofetil

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Anti-FH titerTimepoint: 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;CKD stages 4-5 (eGFR less than 30 ml/min/1.73 m2)Timepoint: 6 months; 1 year	—

Countries

India

Contacts

Public ContactAditi Sinha

All India Institute of Medical Sciences

aditisinhaaiims@gmail.com9899145489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026