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Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00796679
First received: November 20, 2008
Last updated: May 7, 2012
Last verified: May 2012

November 20, 2008
May 7, 2012
October 2008
June 2011   (final data collection date for primary outcome measure)
Change in left ventricular mass index determined by MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796679 on ClinicalTrials.gov Archive Site
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 ]
Change in left atrial and ventricular volumes, systolic and diastolic function, carotid intima-media thickness, flow mediated dilation, serum inflammatory and cardiac biomarkers, intact PTH, 24-hour urine protein and renal function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
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
  • Experimental: 1
    paricalcitol
    Intervention: Drug: paricalcitol
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: paricalcitol
Wang AY, Fang F, Chan J, Wen YY, Qing S, Chan IH, Lo G, Lai KN, Lo WK, Lam CW, Yu CM. Effect of paricalcitol on left ventricular mass and function in CKD--the OPERA trial. J Am Soc Nephrol. 2014 Jan;25(1):175-86. doi: 10.1681/ASN.2013010103. Epub 2013 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00796679
A10-003
Yes
The University of Hong Kong
The University of Hong Kong
Abbott
Principal Investigator: Angela YM Wang, MD, FRCP Queen Mary Hospital, University of Hong Kong
The University of Hong Kong
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP