Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

The University of Hong Kong (HKU)

Status

Completed

Conditions

Chronic Kidney Disease

Treatments

Drug: paricalcitol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00796679

A10-003

Details and patient eligibility

About

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.

Full 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 a normal echocardiogram, with left ventricular hypertrophy, left ventricular dilatation and systolic dysfunction occurring in 40.7%, 28% and 15.6% of patients, respectively. In addition, these patients are at an accelerated risk of developing atherosclerosis. The Kidney Disease Outcome Quality Initiative guideline recently raised concerns of a high prevalence of vitamin D deficiency in chronic kidney disease patients not yet requiring dialysis treatment. In addition, very recent data suggested that vitamin D deficiency is an important predictor of mortality in end-stage renal disease patients. Furthermore, hemodialysis patients treated with paricalcitol, a selective vitamin D receptor activator, showed a significantly lower risk of cardiovascular death than those not receiving vitamin D therapy. A number of studies also showed positive benefit of vitamin D receptor activator treatment on regression of left ventricular hypertrophy in dialysis patients. However, there is so far no data in patients with stage 3 and 4 chronic kidney disease where a high prevalence of vitamin D deficiency and cardiac hypertrophy has been reported.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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