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Daily corticosteroids to prevent infection associated relapses in patients with frequently relapsing nephrotic syndrome

Daily corticosteroids to prevent infection associated relapses in patients with frequently relapsing nephrotic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000245
Enrollment
100
Registered
2009-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Prednisolone at 0.75 mg/kg every day for 7 days during an infection.: Pednisolone at 0.75 mg/kg every day for 7 days during infection then continued on alternate day at 0.5-0.75 mg/kg C

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with idiopathic, steroid responsive nephrotic syndrome, 1 to 16 years' old, having frequent relapses or steroid dependence shall be studied. Only patients with a minimum follow up of 9 months at this center will be included. Standard definitions will be used for defining the course of nephrotic syndrome

Exclusion criteria

Exclusion criteria: 1. Patients with impaired renal functions (serum creatinine > 1.2 mg/dl or urea > 45 mg/dl, confirmed once over a period of 2 weeks). 2. Patients with initial or late steroid resistance. 3. Patients who have received immunosuppressive medications, other than oral prednisolone, in the preceding 6 months. 4. Patients who require prednisolone at dose exceeding 1 mg/kg on alternate days for maintaining remission. 5. Patients with features of steroid toxicity (obesity, cataract, hypertension) (Table 1). 6. Patients staying more than 100 km from the Institute or those who not willing to come for clinic visits every two months.

Design outcomes

Primary

MeasureTime frame
Relapse rates (episodes/patient per year) will be compared in both groups, in the six months prior and during one-year follow up.Timepoint: 12 months

Secondary

MeasureTime frame
cumulative dose of prednisolone administered (mg/kg per day) will be compared 6-months prior and during the period of the study in the two groups. The frequencies of intercurrent infections shall be determined.Timepoint: 12 months

Countries

India

Contacts

Public ContactDr. Arvind Bagga
arvindbagga@hotmail.com011-26593472

Outcome results

None listed

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