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Calcitriol in the Treatment of Immunoglobulin A Nephropathy

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ClinicalTrials.gov Identifier: NCT00862693
Recruitment Status : Unknown
Verified March 2009 by Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : March 17, 2009
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Peking University First Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2009
First Posted Date  ICMJE March 17, 2009
Last Update Posted Date February 17, 2011
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
decline of urine protein [ Time Frame: 12 months treatment ]
analysis urine protein after 12 months treatment
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2009)
at change in the degree of proteinuria [ Time Frame: rate of decline of estimated GFR after six months treatment ]
Change History Complete list of historical versions of study NCT00862693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcitriol in the Treatment of Immunoglobulin A Nephropathy
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glomerulonephritis
  • Autoimmune Diseases
Intervention  ICMJE Drug: Calcitriol
0.5ug/Biw
Study Arms  ICMJE
  • Experimental: 1 calcitriol
    calcitriol 0.5ug/BIW for 12 months
    Intervention: Drug: Calcitriol
  • No Intervention: 2
    no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 16, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862693
Other Study ID Numbers  ICMJE 20090315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Renal Division, Peking University First Hospital, Key Laboratory of Renal Disease, Ministry of Health of China
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University First Hospital
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP