Chronic Kidney Disease, Proteinuria
Conditions
Keywords
mild proteinuria, calcitriol, renal function, blood pressure
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.
Interventions
DRUGCalcitriol
Calcitriol 0.5 ug/BIW for 24 weeks.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage change of proteinuia | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| the proportion of patients achieving at least a 15% decrease in proteinuria | 24 weeks |
Other
| Measure | Time frame |
|---|---|
| mean change of renal function (serum creatine, cystatin C, eGFR) | 24 weeks |
| blood pressure | 24 weeks |
Countries
China
Contacts
Primary ContactJing Chen, M.D. PhD
Backup ContactLi You, M.D. PhD
Outcome results
None listed