Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
Conditions
Interventions
Intervention1: Tacrolimus prolonged release preparation (ODVenta®): Therapy with ODVenta® will be administered at the same dose as the total daily of twice daily tacrolimus that the patient was alre
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Idiopathic steroid-sensitive nephrotic syndrome 2. CNI dependent nephrotic syndrome, as defined by all of the following: (i) frequent relapses or steroid dependence; (ii) failure of two or more immunosuppressive agents; (iii) sustained remission or infrequent relapses during therapy with CNI 3. Therapy with oral tacrolimus twice daily for 6-30 months 4. Tacrolimus 12-hr trough level of 4-7 ng/mL 5. No or one relapse in the last 6 months 6. Currently in remission 7. Written informed consent
Exclusion criteria
Exclusion criteria: Secondary nephrotic syndrome Steroid resistant nephrotic syndrome Histology other than minimal change disease, focal segmental glomerulosclerosis or mesangioproliferative glomerulonephritis Frequent relapses during therapy with tacrolimus Therapy with either CNI for a cumulative duration of >30 months Therapy with immunosuppressive agents other than prednisolone and tacrolimus in the past 6 months (e.g., cyclosporine, rituximab, mycophenolate mofetil or cyclophosphamide) Estimated glomerular filtration rate (eGFR) less than 60 ml/min per 1.73 m2 Infection with hepatitis B or C or HIV Seizures or recurrent headache during therapy with tacrolimus Concomitant therapy with an agent that interferes with bioavailability of tacrolimus Glycosylated hemoglobin (HbA1c) >5.7% or fasting blood glucose >100 mg/dL Hypomagnesemia despite therapy with magnesium oxide (<= 1.7 mg/dL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with stable remissionTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in estimated GFR, HbA1c, and total and LDL cholesterolTimepoint: 6 months;Number of relapsesTimepoint: 6 months;Proportion with treatment failureTimepoint: 6 months;The proportion of children with sustained remission Timepoint: 6 months;Total daily dose to trough ratio changeTimepoint: after 6 months of therapy | — |
Countries
India
Contacts
Public ContactSrinivasavaradan Govindarajan
All India institute of medical sciences, New Delhi
Outcome results
None listed