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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Withdrawn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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 2, 2008
Last Updated
July 31, 2015
Sponsor
Chinese University of Hong Kong
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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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