Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chinese University of Hong Kong
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
