Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Immunoglobulin A (IgA) nephropathy is the most 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. Calcitriol, an active form of vitamin D, is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. Therefore, the investigators plan to conduct a open-label single-arm study to evaluate the safety and efficacy of calcitriol in the treatment of IgA nephropathy. Ten patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 12 weeks. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of calcitriol in the treatment of IgA nephropathy, which is a major cause of dialysis-dependent renal failure.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
aged 18-65 years
biopsy-confirmed IgA nephropathy
proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
corrected serum calcium level M 2.45 mmol/l
willingness to give written consent and comply with the study protocol
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 vitamin D analogue
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 vitamin D analogs