Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

This study has been withdrawn prior to enrollment.
(Funding problem.)
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00599963
First received: January 2, 2008
Last updated: January 29, 2009
Last verified: January 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study

Resource links provided by NLM:


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
Experimental: 1
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
Active Comparator: 2
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
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, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin A
Immunoglobulins
Antibodies
Ergocalciferols
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 31, 2014