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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 10 August 2015
Main ID:  NCT00508898
Date of registration: 27/07/2007
Prospective Registration: Yes
Primary sponsor: Chinese University of Hong Kong
Public title: The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Scientific title: The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
Date of first enrolment: May 2008
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT00508898
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Hong Kong
Contacts
Name:     Cheuk-Chun Szeto, MD
Address: 
Telephone:
Email:
Affiliation:  Chinese University of Hong Kong
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Nephritis
Proteinuria
Systemic Lupus Erythematosus
Intervention(s)
Drug: Multivitamin
Drug: Calcitriol
Primary Outcome(s)
change in proteinuria [Time Frame: one year]
Secondary Outcome(s)
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]
Secondary ID(s)
CRE-2007.261-T
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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