IgA Nephropathy
Conditions
Brief summary
Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. However, calcitriol, the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment at present.
Interventions
DRUGparicalcitol
paricalcitol 1 mg/day
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* aged 18-65 years * biopsy-confirmed IgA nephropathy * proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months * estimated glomerular filtration rate \> 60 ml/min/1.73m2 * corrected serum calcium level \> or = 2.45 mmol/l * willingness to give written consent and comply with the study protocol
Exclusion criteria
* Pregnancy, lactating or childbearing potential without effective method of birth control * Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication * History of malignancy, including leukemia and lymphoma within the past 2 years * Systemic infection requiring therapy at study entry * Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension * History of drug or alcohol abuse within past 2 years * Participation in any previous trial on paricalcitol * Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months * Patients receiving treatment of corticosteroid * On other investigational drugs within last 30 days * History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study * History of non-compliance * Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in the degree of proteinuria | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers | 12 weeks |
Countries
Hong Kong
Outcome results
None listed