NCT00428246

Brief Summary

The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Shorter than P25 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

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 3, 2009

Completed
Last Updated

June 3, 2009

Status Verified

April 1, 2009

Enrollment Period

8 months

First QC Date

January 25, 2007

Results QC Date

April 6, 2009

Last Update Submit

April 6, 2009

Conditions

Chronic Kidney DiseaseEndothelial DysfunctionInflammationHypertension

Keywords

Chronic Kidney DiseaseEndothelial dysfunctionInflammationHypertensionparicalcitolBlood pressureVitamin DGlomerular filtration rate

Outcome Measures

Primary Outcomes (2)

  • Anti-Inflammatory Effects of Paricalcitol

    change in hsCRP level from baseline to 4 weeks

    6 weeks

  • Endothelial Protectant Effects of Paricalcitol

    6 weeks

Secondary Outcomes (2)

  • Effect of Paricalcitol on Hypertension

    6 weeks

  • Effect of Paricalcitol on Kidney Function

    6 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

1 mcg paricalcitol

Drug: paricalcitol

2

ACTIVE COMPARATOR

2 mcg paricalcitol

Drug: paricalcitol

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

paricalcitolDRUG

1 mcg or 2 mcg for 4 weeks.

Also known as: Zemplar
12
PlaceboDRUG

Placebo

3

Eligibility Criteria

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

You may qualify if:

  • Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
  • Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
  • Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
  • Hemoglobulin A1C\< 11%

You may not qualify if:

  • Patients taking vitamin D analogs
  • Calcium\> 10 mg/dL
  • Phosphorus\>6 mg/dL
  • Patients with anticipated need of dialysis in the next 6 weeks
  • Patients unstable in the opinion of the investigator
  • Patients who have emergent need for starting IV iron
  • Patients who will be started on statins within the next 6 weeks
  • Patients currently taking PDE5 inhibitors
  • Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
  • Patients known to be HIV positive
  • Patients who can not give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard A. Rodebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Alborzi P, Patel NA, Peterson C, Bills JE, Bekele DM, Bunaye Z, Light RP, Agarwal R. Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. Hypertension. 2008 Aug;52(2):249-55. doi: 10.1161/HYPERTENSIONAHA.108.113159. Epub 2008 Jul 7.

    PMID: 18606901RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicInflammationHypertension

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 SymptomsVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Rajiv Agarwal
Organization
Indiana University
ragarwal@iupui.edu
317-988-2241

Study Officials

  • Rajiv Agarwal, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

November 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 3, 2009

Results First Posted

June 3, 2009

Record last verified: 2009-04

Locations

US(1)