Status:
COMPLETED
Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Abbott
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to test the hypothesis that selective vitamin D receptor activation reduces left ventricular hypertrophy and ameliorates inflammation and atherosclerosis in stage 3 -5 chr...
Detailed Description
Cardiovascular disease is the leading cause of mortality and morbidity in patients with chronic kidney disease. According to a previous study, only 15.6% of the patients beginning dialysis therapy had...
Eligibility Criteria
Inclusion
- Patient with stage 3 -5 chronic kidney disease (that is, eGFR \< 60 ml/min per 1.73m2) diagnosed for more than 2 months and not expected to start dialysis within the next 12 months, and
- Patient with screening echocardiography showing evidence of left ventricular hypertrophy
- Patient has not received vitamin D therapy in the previous 4 weeks
- For entry into the Treatment Phase, the subject must have:
- screening iPTH \>= 55 pg/ml or 5.8pmol/L (determined by the Nichols second-generation assay or similar assay)
- serum calcium \< 10.2 mg/dL (2.55 mmol/L)
- serum phosphorus =\< 5.2mg/dL (1.68mmol/L)
- Ca\*P product \< 54 mg2/dL2 (4.36mmol2/L2)
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is of childbearing potential and practicing birth control measures.
- Patients who provide informed consent for the study
Exclusion
- Patient with a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
- Patient with history of renal stones
- Patient with current malignancy
- Patients with clinically significant gastrointestinal disease or liver disease
- Patient with acute renal failure in the recent three months
- Patient with a history of drug or alcohol abuse within six months prior to the screening phase
- Patient is known to be human immunodeficiency virus (HIV) positive.
- Patient with evidence of poor compliance with diet and medication.
- Patient currently receiving medications that may affect calcium, phosphorus metabolism such as calcitonin, cinacalcet, bisphophonates or vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
- Patients with active granulomatous disease
- Patient with pregnancy
- Patients currently receiving glucocorticoid steroid or other immunosuppressive treatment or had been administered glucocorticoid or other immunosuppressive treatment for more than 14 days within recent 6 months.
- Patients with contraindication for MRI examination
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00796679
Start Date
October 1 2008
End Date
June 1 2011
Last Update
January 10 2017
Active Locations (2)
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1
Queen Mary Hospital
Hong Kong, Hong Kong, 0000
2
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong, 0000