Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00599963

Purpose

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.

Condition	Intervention	Phase
IGA Nephropathy	Drug: paricalcitol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study

Resource links provided by NLM:

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2 Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

change in the degree of proteinuria [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental paricalcitol 1 mg/day for 12 weeks, followed by a washout period of 4 weeks, then crossed over to no treatment for another 12 weeks	Drug: paricalcitol paricalcitol 1 mg/day
2: Active Comparator no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks	Drug: paricalcitol paricalcitol 1 mg/day

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599963

Locations

China
Department of Medicine & Therapeutics, Prince of Wales Hospital
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Cheuk Chun Szeto, MD

Chinese University of Hong Kong

More Information

No publications provided

Responsible Party:	The Chinese University of Hong Kong ( Dr. SZETO, Cheuk Chun )
Study ID Numbers:	CRE-2007.409-T, CRE-2007.409-T
Study First Received:	January 2, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00599963 History of Changes
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study placed in the following topic categories:

Immunoglobulin A
Antibodies
Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Urologic Diseases

Nephritis
Glomerulonephritis, IGA
Kidney Diseases
Berger Disease
Immunoglobulins

Additional relevant MeSH terms:

Immunoglobulin A
Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Urologic Diseases

Nephritis
Physiological Effects of Drugs
Glomerulonephritis, IGA
Kidney Diseases
Pharmacologic Actions
Immunoglobulins

ClinicalTrials.gov processed this record on September 03, 2009