The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria

This study has suspended participant recruitment.
(Funding problem; trial abandoned.)
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00508898
First received: July 27, 2007
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.


Condition Intervention Phase
Systemic Lupus Erythematosus
Nephritis
Proteinuria
Drug: Calcitriol
Drug: Multivitamin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • change in proteinuria [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end points include risk of lupus flare, change in renal function, SLEDAI score, serum and urinary inflammatory markers. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment group
Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.
Drug: Calcitriol
Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
Active Comparator: control group
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
Drug: Multivitamin
Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).

  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
  • clinical quiescent SLE for at least 12 weeks
  • baseline SLEDAI score <= 4
  • history of biopsy-proven lupus nephritis
  • estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
  • proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker for at least 3 months
  • on maintenance dose of prednisolone < 10 mg/day, with or without other immunosuppressive medications
  • corrected serum calcium level < 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 vitamin D analogue
  • Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks. Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D.
  • 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 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: NCT00508898

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Cheuk-Chun Szeto, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: SZETO, Cheuk Chun, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00508898     History of Changes
Other Study ID Numbers: CRE-2007.261-T
Study First Received: July 27, 2007
Last Updated: January 29, 2009
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
lupus nephritis
proteinuria
chronic kidney diseases
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Proteinuria
Autoimmune Diseases
Connective Tissue Diseases
Glomerulonephritis
Immune System Diseases
Kidney Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014