Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00319761
• Date of registration: 27/04/2006
• Prospective Registration: Yes
• Primary sponsor: Chinese University of Hong Kong
• Public title: Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy
• Scientific title: The Safety and Short-Term Efficacy of Calcitriol in the Treatment of Immunoglobulin A Nephropathy
• Date of first enrolment: May 2006
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00319761
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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

- biopsy-confirmed IgA nephropathy

- proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12
weeks despite ACE inhibitor or angiotensin receptor blocker treatment (ramipril 5 mg
daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months

- estimated glomerular filtration rate 15 to 60 ml/min/1.73m2

- corrected serum calcium level M 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 3 months

- Patients receiving treatment of corticosteroid

- 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

IGA Nephropathy

Intervention(s)

Drug: Calcitriol

Primary Outcome(s)

Primary end point of the study is the change in the degree of proteinuria.

Secondary Outcome(s)

Secondary end points include the change in renal function and other serum inflammatory markers.

Secondary ID(s)

CREC-2006.120

Source(s) of Monetary Support

Please refer to primary and secondary sponsors