NCT01003275

Brief Summary

The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

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

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 27, 2013

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

October 26, 2009

Results QC Date

June 18, 2013

Last Update Submit

April 9, 2014

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney diseaseVitamin DParicalcitolPlaceboKidneyRenalOxidative StressImmune cell functionGlucoseGlucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Glucose Area Under the Curve (AUC)

    Glucose AUC during a 2-hour oral glucose tolerance test

    8 weeks

Study Arms (2)

Paricalcitol followed by placebo

ACTIVE COMPARATOR

Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.

Drug: ParicalcitolDrug: Placebo

Placebo followed by paricalcitol

ACTIVE COMPARATOR

Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.

Drug: ParicalcitolDrug: Placebo

Interventions

ParicalcitolDRUG

Two 1 mcg soft gels by mouth daily for 8 weeks

Also known as: Zemplar
Paricalcitol followed by placeboPlacebo followed by paricalcitol
PlaceboDRUG

Two soft gels by mouth daily for 8 weeks

Paricalcitol followed by placeboPlacebo followed by paricalcitol

Eligibility Criteria

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

You may qualify if:

  • Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
  • Fasting glucose 100-125 mg/dL
  • years and older

You may not qualify if:

  • Diagnosed with diabetes mellitus
  • Use of diabetes medications (insulin or oral hypoglycemics)
  • Prior dialysis or transplantation
  • Planning to leave the area within 6 months
  • Participation in another clinical trial within 30 days
  • Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
  • Serum calcium more than 10.2 mg/dL
  • Pregnancy or breast-feeding
  • Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol
  • Incontinent of urine
  • Cancer (other than skin cancer) within 5 years
  • Tuberculosis
  • Sarcoidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • de Boer IH, Sachs M, Hoofnagle AN, Utzschneider KM, Kahn SE, Kestenbaum B, Himmelfarb J. Paricalcitol does not improve glucose metabolism in patients with stage 3-4 chronic kidney disease. Kidney Int. 2013 Feb;83(2):323-30. doi: 10.1038/ki.2012.311. Epub 2012 Aug 22.

    PMID: 22913981RESULT

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
Ian H. de Boer, MD, MS, Associate Professor of Medicine
Organization
University of Washington
deboer@u.washington.edu
2066165403

Study Officials

  • Ian H de Boer, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 28, 2014

Results First Posted

September 27, 2013

Record last verified: 2014-04

Locations

US(1)