Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

NCT00599963 | Withdrawn Phase 3 DMC

• 1 other identifier: CRE-2007.409-T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• change in the degree of proteinuria

  12 weeks

Secondary Outcomes (1)

• rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers

  12 weeks

Study Arms (2)

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

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

Interventions

paricalcitol DRUG

paricalcitol 1 mg/day

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cheuk Chun Szeto, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 24, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 3, 2015

Record last verified: 2009-01

Locations

HK (1)