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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Withdrawn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

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

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

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

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

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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