Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
Drug: paricalcitol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Oral Paricalcitol in Retarding Cardiac Hypertrophy, Reducing Inflammation and Atherosclerosis in Stage 3 - 5 Chronic Kidney Disease |
- Change in left ventricular mass index determined by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Change in left atrial and ventricular volumes, systolic and diastolic function, carotid intima-media thickness, flow mediated dilation, pulse wave velocity, serum inflammatory and cardiac biomarkers, intact PTH, 24-hour urine protein and renal function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
paricalcitol
|
Drug: paricalcitol
oral paricalcitol capsule 1 microgram once daily if iPTH <500pg/mL or 2 microgram once daily if iPTH >=500pg/mL. Thereafter, dose titration in 1 microgram decrement will be done based on safety reasons (that is, for low PTH or high calcium and phosphorus level). The duration of treatment will be for 1 year.
Other Name: Zemplar
|
|
Placebo Comparator: 2
placebo
|
Drug: paricalcitol
oral paricalcitol capsule 1 microgram once daily if iPTH <500pg/mL or 2 microgram once daily if iPTH >=500pg/mL. Thereafter, dose titration in 1 microgram decrement will be done based on safety reasons (that is, for low PTH or high calcium and phosphorus level). The duration of treatment will be for 1 year.
Other Name: Zemplar
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Hong Kong | |
| Queen Mary Hospital | |
| Hong Kong, Hong Kong, 0000 | |
| University of Hong Kong, Queen Mary Hospital | |
| Hong Kong, Hong Kong, 0000 | |
| Principal Investigator: | Angela YM Wang, MD, FRCP | Queen Mary Hospital, University of Hong Kong |
More Information
No publications provided
| Responsible Party: | The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00796679 History of Changes |
| Other Study ID Numbers: | A10-003 |
| Study First Received: | November 20, 2008 |
| Last Updated: | May 7, 2012 |
| Health Authority: | Hong Kong: Ethics Committee Hong Kong: Department of Health |
Keywords provided by The University of Hong Kong:
|
paricalcitol chronic kidney disease cardiac hypertrophy |
Additional relevant MeSH terms:
|
Hypertrophy Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Cardiomegaly Pathological Conditions, Anatomical Urologic Diseases Renal Insufficiency Heart Diseases |
Cardiovascular Diseases Ergocalciferols Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013