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Evaluation of efficacy of add on short course oral enalapril in children with infrequently relapsing nephrotic syndrome aged 1-18 years

Evaluation of efficacy of add on short course oral enalapril in children with infrequently relapsing nephrotic syndrome aged 1-18 years - A open labelled randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076455
Enrollment
82
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Addition of short course of oral enalapril: Participants in this group will receive oral enalapril at a dose of 0.3 mg/kg/day for a duration of 3 days along with standard treatment.The

Sponsors

Surya Prasath.R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 1 to 18 years present to pediatric OPD/IPD with infrequently relapsing nephrotic syndrome. Proteinuria =3+ in dipstick urine test for 3 days Patients who have not received antiproteinuric medications (Amiloride and Enalapril) for the past 4 weeks. Willingness of the patient or guardian to provide informed consent.

Exclusion criteria

Exclusion criteria: Patients with a history of ACEI allergy or intolerance. Patients with renal artery stenosis Patients with a GFR less than 30ml/min Patients with liver failure or hepatic impairment. Patients with a history of malignant hypertension.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure for this study will be the duration of proteinuria till remission. This will be measured as the number of days from the start of treatment to the first day of three consecutive negative or trace urine dipstick tests for proteinTimepoint: Till remission

Secondary

MeasureTime frame
The change in proteinuria from baseline to week 3, 6 and 12 The change in serum albumin from baseline to week 3, 6 and 12 The change in blood pressure from baseline to week 3, 6 and 12 The incidence of adverse events related to enalapril if any Total cumulative steroid doses required in both groups to achieve remission Total number of relapses during the studyTimepoint: Week 3,6,12

Countries

India

Contacts

Public ContactDrPrateek Kumar Panda

AIIMS Rishikesh

vinodmbbs52@gmail.com9648225345

Outcome results

None listed

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