Overview
Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease
Status:
Completed
Completed
Trial end date:
2011-06-01
2011-06-01
Target enrollment:
0
0
Participant gender:
All
All
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 chronic kidney disease.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The University of Hong KongCollaborator:
AbbottTreatments:
Ergocalciferols
Criteria
Inclusion Criteria:- 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 Criteria:
- 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