MedPath

To study the use of calcitriol in reducing protein in urine in patients with kidney damage due to proteinuria.

Phase 3
Conditions
Health Condition 1: null- Chronic Proteinuric Nephropathy
Registration Number
CTRI/2011/10/002086
Lead Sponsor
ICMR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
90
Inclusion Criteria

1.Normal blood pressure on stable doses of antihypertensive drugs for 1 month

2.Estimated GFR 30 -90 ml/min/1.73 m2

3.Children on corticosteroid should be on stable doses of corticosteroids for last 2 month

Exclusion Criteria

Following children will be excluded from the study.

1.Patients below 3 years of age

2.Patients with estimated GFR 30 ml/min/1.73m2

3.Patients with chronic liver disease or deranged transaminase levels (more than 2 times the normal)

4.Patients with phosphorus levels 5.5 mg/dl, current hypercalcemia (serum calcium 10.5 mg/dl) or untreated primary hyperparathyroidism.

5.Patients with hypercalciuria (24 h urinary calcium 4 mg/kg/d)

6.Children residing outside 200km of the Delhi border.

7.History of nephrolithiasis.

8.Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc.

9.Treatment with vitamin D or any of its active metabolites in last 4 weeks

10.Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.

11.Patients with bilateral renal artery stenosis.

12.Patients on immunosuppressive drugs such as cyclophosphamide, calcineurin inhibitors, azathioprine

13.Steroid responsive nephrotic syndrome

14.Patients on high dose (2 mg/kg/d prednisolone or equivalent) or intravenous corticosteroids

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Degree of ProteinuriaTimepoint: at 0 and 6 months
Secondary Outcome Measures
NameTimeMethod
intact parathormone, 25OH vitamin D, highly selective C reactive protein, estimated Glomerular filtration rate, <br/ ><br>Carotid intimal medial thickness, Flow mediated dilatation of brachial artery, <br/ ><br>Occurence of hypercalcemia hyperposphatemiaTimepoint: at 0 and 6 months
© Copyright 2025. All Rights Reserved by MedPath