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Calcitriol in the Treatment of Immunoglobulin A Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Glomerulonephritis Autoimmune Diseases Drug: Calcitriol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2009
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: 1 calcitriol
calcitriol 0.5ug/BIW for 12 months
Drug: Calcitriol

No Intervention: 2
no intervention

Primary Outcome Measures :
  1. decline of urine protein [ Time Frame: 12 months treatment ]
    analysis urine protein after 12 months treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00862693

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Contact: Hong Zhang, Prof +86-10-66551122-2288

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China, Beijing
Renal Division, Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Hong Zhang, Prof    +86-10-66551122-2288   
Sponsors and Collaborators
Peking University First Hospital
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Responsible Party: Renal Division, Peking University First Hospital, Key Laboratory of Renal Disease, Ministry of Health of China Identifier: NCT00862693    
Other Study ID Numbers: 20090315
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: March 2009
Keywords provided by Peking University First Hospital:
Immunoglobulin A
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents