Home » Trials » SLCTR/2016/027


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

SLCTR Registration Number

SLCTR/2016/027


Date of Registration

02 Nov 2016

The date of last modification

Dec 05, 2016



Application Summary


Scientific Title of Trial

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


Public Title of Trial

A comparative study on steroid therapy in children with nephrotic syndrome


Disease of Health Condition(s) Studied

Nephrotic syndrome


Scientific Acronym

None


Public Acronym

None


Brief title

A comparative study on Steroid therapy in nephrotic syndrome.


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

3.2, 11.8.2015 (ERC: Ruhuna)


Trial Details


What is the research question being addressed?

How does the different dosing and duration of steroid therapy affect the duration of remission, relapse rate, and the time taken for the development of frequently relapsing nephrotic syndrome or steroid dependency


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Treatment


Purpose


Intervention(s) planned

  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 arms
    i. Experimental group – 7 month treatment arm. (Jayantha2002a)
    ii. Control group – 6 month treatment arm (KDIGO regime)

    b. Patients presenting with relapsing nephrotic syndrome will be allocated into 2 treatment arms.
    i. Experimental group – relapse regime of the 7 month treatment arm (Jayantha2002b)
    ii. Control group – Relapse regime of the 6month treatment arm (KDIGO relapse regime)

  3. Method of randomization and the allocation of patients
    Table of random numbers will be used. A randomization list will be generated by using the digits 0-9, 1 per treatment assignment starting with the top row and working downwards. 7 months treatment arm assigned for digits 0-4 and the KDIGO treatment arm assigned to digits 5-9. Randomization of patients with 1st episode and patients presenting with relapsing nephrotic syndrome will be done separately.

  4. Details of the intervention in each arm a. First episode
    i. 7 Months treatment arm(Jayantha 2002a)
    Prednisolone: 60mg/m2/day for 28 days; 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; 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

    ii. 6 month treatment arm(KDIGO)
    Prednisolone: 60mg/m2/day for 42 days; 40mg/m2/eod for 42 days; 30mg/m2/eod for 28 days; 22.5mg/m2/eod for 28 days; 15mg/m2/eod 28 days
    Relapses will be treated with Prednisolone 60mg/m2 daily until urine is protein free for 3 days; then 40mg/m2/eod for 28 days

    b. Patients presenting with relapsing nephrotic syndrome
    i. 7 Months relapsing treatment arm(Jayantha 2002b) Prednisolone: 60mg/m2 daily until urine is protein free for 3 days; then 60mg/m2/every other day 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; 10mg/m2/eod for 28 days

    ii. 6 month relapse treatment arm(KDIGO)
    Prednisolone: 60mg/m2 daily until urine is protein free for 3 days; then 40mg/m2/eod for 28 days


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

  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


Primary outcome(s)

  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.

Primary outcome(s) - Time of assessment(s)

Monthly until remission is reached, and then every 2 months for a period of three years


Secondary outcome

Stunting Obesity Cataract


Secondary outcome(s) - Time of assessment(s)

Height and weight will be measured every month while on treatment and every 3months while in remission and plotted in the centile charts



Target number/sample size

64


Countries of recruitment

Sri Lanka


Anticipated start date

2016-11-02


Anticipated end date

2019-10-30


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Ruhuna on 15th September 2015 (Ref: 3.2, 11.8.2015)


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Professor U.K. Jayantha
Chair and Professor of Paediatrics
Department of Paediatrics. Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka
Tel: 0777920414
Mob: 0777920414

u_k_jayantha@yahoo.com

Contact Person for Public Queries

Dr. U.K.S.R. Udupitiya
Co- researcher.
University Renal Clinic, Teaching Hospital, Karapitiya
Tel: 0776011665
Mob: 0776011665

u.k.s.r.udupitiya@gmail.com


Primary study sponsor/organization

University Renal Clinic

Teaching Hospital Karapitiya. Sri Lanka.
Tel: 0777920414


Secondary study sponsor (If any)

None