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

Primary Purpose

Systemic Lupus Erythematosus, Nephritis, Proteinuria

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Calcitriol
Multivitamin
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring lupus nephritis, proteinuria, chronic kidney diseases, SLE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    treatment group

    control group

    Arm Description

    Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.

    Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).

    Outcomes

    Primary Outcome Measures

    change in proteinuria

    Secondary Outcome Measures

    Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers.

    Full Information

    First Posted
    July 27, 2007
    Last Updated
    July 31, 2015
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00508898
    Brief Title
    The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
    Official Title
    The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding problem; trial abandoned.
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus, Nephritis, Proteinuria
    Keywords
    lupus nephritis, proteinuria, chronic kidney diseases, SLE

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Description
    Patients will receive calcitriol at a fixed dose of 1 mcg twice weekly.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
    Intervention Type
    Drug
    Intervention Name(s)
    Calcitriol
    Intervention Description
    Patients will receive calcitriol (oral capsule) at a fixed dose of 1 mcg twice weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    Multivitamin
    Intervention Description
    Patients will receive multivitamin 1 tab daily (with vitamin D2 300 IU).
    Primary Outcome Measure Information:
    Title
    change in proteinuria
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Secondary end points include risk of lupus flare, change in renal function, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, serum and urinary inflammatory markers.
    Time Frame
    one year

    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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheuk-Chun Szeto, MD
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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