NCT00915876

Brief Summary

This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

December 2, 2016

Completed
Last Updated

December 2, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

June 5, 2009

Results QC Date

October 7, 2016

Last Update Submit

October 7, 2016

Conditions

Chronic Kidney Disease

Keywords

chronic kidney diseaseVitamin D

Outcome Measures

Primary Outcomes (1)

  • Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56

    Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56

    Day 28 and Day 56

Study Arms (2)

Paricalcitol

ACTIVE COMPARATOR
Drug: Paricalcitol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ParicalcitolDRUG

paricalcitol 1 mcg QD x 8 weeks

Paricalcitol
PlaceboDRUG

Placebo for Paricalcitol 1 mcg QD x 8 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females ≥ 18 years of age at the start of screening
  • CKD with eGFR 15-60 mL/min/1.73m2 by MDRD
  • Not expected to start dialysis for 4 months
  • Serum intact PTH 70-200 pg/mL during screening period
  • On stable ACEI/ARB regimen for 30 days prior to screening

You may not qualify if:

  • History of any of the following diseases:
  • congestive heart failure
  • MI within the last 6 months
  • history of cerebrovascular accident
  • significant valvular disease
  • malignancy
  • Currently taking any vitamin D products
  • Mean systolic blood pressure values \> 190 or diastolic blood pressure values \> 100 mm/Hg during the preceding 30 day period prior to screening
  • Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
  • Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P \> 55 mg2/dL2
  • Currently receiving erythropoiesis stimulating agent or intravenous iron therapy
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center South Clinical Campus

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Amy Pai
Organization
University of Michigan
amypai@med.umich.edu
7346470005

Study Officials

  • Amy Pai, Pharm.D.

    Albany College of Pharmacy and Health Sciences

    PRINCIPAL INVESTIGATOR

  • Amy Pai, PharmD

    Albany College of Pharmacy and Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 8, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 2, 2016

Results First Posted

December 2, 2016

Record last verified: 2016-10

Locations

US(1)