Overview

Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Hong Kong
Collaborator:
Abbott
Treatments:
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