Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Fudan University

Status and phase

Unknown

Phase 4

Conditions

Chronic Kidney Disease

Proteinuria

Treatments

Drug: Calcitriol

Study type

Interventional

Funder types

Other

Identifiers

NCT01820832

Calcitriol-MP-1

Details and patient eligibility

About

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

Full 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 reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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