Efficacy of oral galactose in in Children with multi drug Resistant Nephrotic Syndrome

Phase 3

• Conditions: Health Condition 1: null- Children with Multidrug Resistant Nephrotic SyndromeHealth Condition 2: N041- Nephrotic syndrome with focal andsegmental glomerular lesionsHealth Condition 3: N040- Nephrotic syndrome with minor glomerular abnormality

• Registration Number: CTRI/2017/12/010830
• Lead Sponsor: yes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age 1-18 years

2.Multidrug resistant nephrotic syndrome as demonstrated by non-responsiveness to oral prednisolone 60mg/m2/day given for 4 weeks and non-responsiveness to tacrolimus or ciclosporin given for at least 3 months (uPCR > 2 mg/mg).

3.Biopsy proven focal segmental glomerulosclerosisor minimal change nephropathy

4.eGFR >60ml/min/1.73m2, stable during the preceding 3 months

5.Discontinuation of immunosuppressive medications at least 1 month prior to screening

6.Stable RAS antagonist (ACE inhibitor or AT1 receptor blocker) therapy (no dose change during previous month)

Exclusion Criteria

1.Galactosemia or other disorder of carbohydrate metabolism

2.Type 1 diabetes mellitus

3.Secondary MDR-NS due to HIV, Hepatitis B, tuberculosis

4.Chronic kidney disease stage III-V

5.Expected non-compliance with medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified