Calcitriol in the Treatment of Immunoglobulin A Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Peking University First Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT00862693
First received: March 16, 2009
Last updated: February 16, 2011
Last verified: March 2009
  Purpose

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 Intervention Phase
Glomerulonephritis
Autoimmune Diseases
Drug: Calcitriol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • decline of urine protein [ Time Frame: 12 months treatment ] [ Designated as safety issue: Yes ]
    analysis urine protein after 12 months treatment


Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 calcitriol
calcitriol 0.5ug/BIW for 12 months
Drug: Calcitriol
0.5ug/Biw
No Intervention: 2
no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862693

Contacts
Contact: Hong Zhang, Prof +86-10-66551122-2288 hongzh@bjmu.edu.cn

Locations
China, Beijing
Renal Division, Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Hong Zhang, Prof    +86-10-66551122-2288    hongzh@bjmu.edu.cn   
Sponsors and Collaborators
Peking University First Hospital
  More Information

No publications provided

Responsible Party: Renal Division, Peking University First Hospital, Key Laboratory of Renal Disease, Ministry of Health of China
ClinicalTrials.gov Identifier: NCT00862693     History of Changes
Other Study ID Numbers: 20090315
Study First Received: March 16, 2009
Last Updated: February 16, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University First Hospital:
Immunoglobulin A
Antibodies
treatment

Additional relevant MeSH terms:
Autoimmune Diseases
Glomerulonephritis
Glomerulonephritis, IGA
Immune System Diseases
Nephritis
Kidney Diseases
Urologic Diseases
Calcitriol
Immunoglobulin A
Immunoglobulins
Antibodies
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Immunologic Factors

ClinicalTrials.gov processed this record on July 20, 2014