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

A 12-Week Placebo-Controlled Randomized Trial of Oral Galactose for Reduction of Proteinuria in Children with Multi-Drug Resistant Nephrotic Syndrome - GALANT

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010830

Enrollment

Registered

2017-12-11

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

Health Condition 1: null- Children with Multidrug Resistant Nephrotic Syndrome Health Condition 2: N041- Nephrotic syndrome with focal andsegmental glomerular lesions Health Condition 3: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Oral galactose, followed by sucrose: Group A (treatment group): Phase 1: Galactose, 0.2g/kg/dose, administered in two oral doses per day for 90 days Phase 2: Sucrose, 0.2g/kg/dose, adm

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Relative change in urinary protein/creatinine ratio (uPCr) after the treatment period of three months compared to baseline Timepoint: Enrollment period: 30 months Study period per patient:6 months First patient in to last patient out: 36 months	—

Secondary

Measure	Time frame
1.Rate of patients with at least 30% decrease of uPCrafter three months exposure 2.Absolute change in serum albumin level after three months exposure 3.% patients with at least 5 g/L increase in serum albumin level after three months of exposure 4. % patients with at least 5 g/L decrease in serum albumin level three months after exposure 5. % patients discontinuing study drug due to adverse effects Timepoint: Every 3 months	—

Measure

Time frame

1.Rate of patients with at least 30% decrease of uPCrafter three months exposure 2.Absolute change in serum albumin level after three months exposure 3.% patients with at least 5 g/L increase in serum albumin level after three months of exposure 4. % patients with at least 5 g/L decrease in serum albumin level three months after exposure 5. % patients discontinuing study drug due to adverse effects Timepoint: Every 3 months

—

Countries

India

Contacts

Public ContactDr Akanksha Singh

Institute of Medical Sciences

opmpedia@yahoo.co.uk09415251328

Outcome results

None listed

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