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

• 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• Recruitment status: Withdrawn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
• 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