Status:
UNKNOWN
Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
Lead Sponsor:
Huashan Hospital
Conditions:
Chronic Kidney Disease
Proteinuria
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The safety and efficacy of Caltriol on mild proteinuria (\<1.0g/d) reduction in CKD patients.
Detailed Description
Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01820832
Start Date
March 1 2013
End Date
June 1 2015
Last Update
March 29 2013
Active Locations (1)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040