Clinical trial NCT01820832: Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
Official title: Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Proteinuria
Keywords: mild proteinuria
calcitriol
renal function
blood pressure
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: the percentage change of proteinuia
timeFrame: 24 weeks
Secondary outcomes:
measure: the proportion of patients achieving at least a 15% decrease in proteinuria
timeFrame: 24 weeks
Other outcomes:
measure: mean change of renal function (serum creatine, cystatin C, eGFR)
timeFrame: 24 weeks
measure: blood pressure
timeFrame: 24 weeks
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Division of Nephrology, Huashan Hospital, Fudan University
name: Jing Chen, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References: