Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT00599963
• Date of registration: 02/01/2008
• Prospective Registration: No
• Primary sponsor: Chinese University of Hong Kong
• Public title: Paricalcitol for the Treatment of Immunoglobulin A Nephropathy
• Scientific title: Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
• Date of first enrolment: January 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00599963
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China, 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 3 consecutive samples within 12
weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril
5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months

- estimated glomerular filtration rate > 60 ml/min/1.73m2

- corrected serum calcium level > or = 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 paricalcitol

- 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 paricalcitol or other 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: paricalcitol

Primary Outcome(s)

change in the degree of proteinuria [Time Frame: 12 weeks]

Secondary Outcome(s)

rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers [Time Frame: 12 weeks]

Secondary ID(s)

CRE-2007.409-T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors