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A comparative study on steroid therapy in children with nephrotic syndrome

A randomized control trial on the efficacy of two different prolonged corticosteroid regimes in children with steroid sensitive nephrotic syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2016/027
Enrollment
64
Registered
2016-11-02
Start date
2016-11-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Nephrotic syndrome

Interventions

1. Study Setting – University Renal Clinic-Teaching Hospital, Karapitiya,Sri Lanka 2. Number of Arms - 4 a. Patients with 1st episode of nephrotic syndrome will be allocated into 2 treatment arm
60mg/m2/eod for 28 days
50 mg/m2/eod for 28 days
40mg/m2/eod for 28 days
30mg/m2/eod for 28 days
20mg/m2/eod for 28days
10 mg/m2 eod for 28 days Relapses will be treated with Prednisolone 60mg/m2 daily until urine is protein free for 3 days
then 60mg/m2/eod for 28 days
30mg/m2</

Sponsors

University Renal Clinic
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients presenting with nephrotic syndrome between 1 yr to 12 yrs of age. 2. 1st episode of nephrotic syndrome, defined as patients with gross proteinuria (+++ or more) with UPcr > 200mg/mmol hypoalbuminemia (albumin>2.5g/dl) and odema. 3. Relapse of nephrotic syndrome, defined as gross proteinuria of +++ or more or UPcr >200mg/mmol for more than 3 days in a child who has been previously diagnosed of having nephrotic syndrome.

Exclusion criteria

Exclusion criteria: 1. Patients who are resistance to prednisolone, defined as Faliure to achieve remission after 28 days of daily prednisolone given at a dose of 60mg/m2/day 2. Remission achieved after more than 28 days of daily prednisolone. 3. Nephroic syndrome secondary to systemic diseases 4. Patients having gross hematuria

Design outcomes

Primary

MeasureTime frame
1. Duration of remission – Time Period from the initial remission to the 1st relapse. 2. Relapse rate – Number of relapses per year. 3. Duration to become Steroid dependent or Frequent Relapsing. [Monthly until remission is reached, and then every 2 months for a period of three years]

Secondary

MeasureTime frame
Stunting Obesity Cataract [Height and weight will be measured every month while on treatment and every 3months while in remission and plotted in the centile charts ]

Countries

Sri Lanka

Contacts

Public ContactProfessor U.K. Jayantha

Chair and Professor of Paediatrics

u_k_jayantha@yahoo.comTel: 0777920414

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026