Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Calcitriol; Cholecalciferol

Criteria

Inclusion Criteria:

• aged 18-75 years

• clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis

• proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month

• estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2

• corticosteroid and immunosuppressive agents withdrawal for at least 6 months

• normal blood pressure

• serum intact parathyroid hormone (iPTH) level >20pg/mL

• corrected serum calcium level < or = 2.55 mmol/L

• serum phosphorus level < or = 1.68 mmol/L

• 24 hours urinary calcium excretion level < or = 7.5 mmol

• not receive treatment of vitamin D or its analogue within 6 months

• willigness to give written consent and comply with the study protocol

Exclusion Criteria:

• history of sensitivity or allergy to calcitriol or other vitamin D analogs

• pregnancy, lactating women

• history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension

• history of malignancy

• history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases

• patients receiving drugs contains of calcium

• patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption

• participation in any other trials within 1 month

• history of non-compliance