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Calcitriol in the Treatment of Immunoglobulin A Nephropathy

Primary Purpose

Glomerulonephritis, Autoimmune Diseases

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Calcitriol
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis focused on measuring Immunoglobulin A, Antibodies, treatment

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 > 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or 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

  • Renal Division, Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1 calcitriol

2

Arm Description

calcitriol 0.5ug/BIW for 12 months

no intervention

Outcomes

Primary Outcome Measures

decline of urine protein
analysis urine protein after 12 months treatment

Secondary Outcome Measures

Full Information

First Posted
March 16, 2009
Last Updated
February 16, 2011
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00862693
Brief Title
Calcitriol in the Treatment of Immunoglobulin A Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University First Hospital

4. Oversight

5. Study Description

Brief Summary
Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol 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
Glomerulonephritis, Autoimmune Diseases
Keywords
Immunoglobulin A, Antibodies, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 calcitriol
Arm Type
Experimental
Arm Description
calcitriol 0.5ug/BIW for 12 months
Arm Title
2
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Description
0.5ug/Biw
Primary Outcome Measure Information:
Title
decline of urine protein
Description
analysis urine protein after 12 months treatment
Time Frame
12 months treatment

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 > 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zhang, Prof
Phone
+86-10-66551122-2288
Email
hongzh@bjmu.edu.cn
Facility Information:
Facility Name
Renal Division, Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang, Prof
Phone
+86-10-66551122-2288
Email
hongzh@bjmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Calcitriol in the Treatment of Immunoglobulin A Nephropathy

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