Paricalcitol for the Treatment of Immunoglobulin A Nephropathy
Primary Purpose
IgA Nephropathy
Status
Withdrawn
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
paricalcitol
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy
Eligibility 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
Sites / Locations
- Department of Medicine & Therapeutics, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
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
no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks
Outcomes
Primary Outcome Measures
change in the degree of proteinuria
Secondary Outcome Measures
rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers
Full Information
NCT ID
NCT00599963
First Posted
January 2, 2008
Last Updated
July 31, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00599963
Brief Title
Paricalcitol for the Treatment of Immunoglobulin A Nephropathy
Official Title
Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Funding problem.
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Intervention Description
paricalcitol 1 mg/day
Primary Outcome Measure Information:
Title
change in the degree of proteinuria
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheuk Chun Szeto, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine & Therapeutics, Prince of Wales Hospital
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Paricalcitol for the Treatment of Immunoglobulin A Nephropathy
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