Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

NCT00796679 | Completed DMC

• 1 other identifier: A10-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

paricalcitol; chronic kidney disease; cardiac hypertrophy

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular mass index determined by MRI

  1 year

Secondary Outcomes (1)

• 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

  1 year

Study Arms (2)

1

EXPERIMENTAL

paricalcitol

Drug: paricalcitol

2

PLACEBO COMPARATOR

placebo

Drug: paricalcitol

Interventions

paricalcitol DRUG

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.

Also known as: Zemplar

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Abbott: collaborator

Study Sites (2)

Queen Mary Hospital

Hong Kong, 0000, Hong Kong

Location

University of Hong Kong, Queen Mary Hospital

Hong Kong, 0000, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 24052631 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiomegaly

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical

Study Officials

• Angela YM Wang, MD, FRCP

  Queen Mary Hospital, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)