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Vitamin D, Insulin Resistance and Inflammation in ESRD

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

paricalcitol

cinacalcet

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring insulin resistance, end stage renal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

CKD and receiving hemodialysis for ≥ 3months
Kt/V ≥ 1.2
≥ 18 years of age
Medically stable
AVF or PTFE dialysis access
No acute inflammatory disease within 4 weeks prior to the study
On stable dose of Paricalcitol for 4 weeks prior to the study
iPTH value between 150 - 1500 within the past 3 months
Ca < 10.5
PO4 < 10

Exclusion Criteria:

Pregnancy
Intolerance to the study medication
Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
Type 1 Diabetes mellitus
Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10)
Hospitalization within 1 month prior to the study
Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 250 ml/min)
Presence of hemodialysis catheter
Patients receiving steroids and/or other immunosuppressive agents (> 10 mg prednisone qd)
BMI < 25 and > 45

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

SOC medication for treatment of renal osteodystrophy

alternate SOC medication for treatment of renal osteodystrophy

Outcomes

Primary Outcome Measures

An improvement in insulin sensitivity

Secondary Outcome Measures

A change in insulin signaling

A decrease in concentration of plasma pro-inflammatory cytokines

Full Information

NCT ID

NCT00656032

First Posted

April 4, 2008

Last Updated

January 9, 2012

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00656032

Brief Title

Vitamin D, Insulin Resistance and Inflammation in ESRD

Official Title

Vitamin D, Insulin Resistance and Inflammation in ESRD

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

insulin resistance, end stage renal disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

SOC medication for treatment of renal osteodystrophy

Arm Title

Arm Type

Active Comparator

Arm Description

alternate SOC medication for treatment of renal osteodystrophy

Intervention Type

Other

Intervention Name(s)

paricalcitol

Other Intervention Name(s)

zemplar

Intervention Description

1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks

Intervention Type

Other

Intervention Name(s)

cinacalcet

Other Intervention Name(s)

sensipar

Intervention Description

0 to 180 mg administered orally every day for either 8 weeks or 16 weeks

Primary Outcome Measure Information:

Title

An improvement in insulin sensitivity

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

A change in insulin signaling

Time Frame

8 weeks

Title

A decrease in concentration of plasma pro-inflammatory cytokines

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: CKD and receiving hemodialysis for ≥ 3months Kt/V ≥ 1.2 ≥ 18 years of age Medically stable AVF or PTFE dialysis access No acute inflammatory disease within 4 weeks prior to the study On stable dose of Paricalcitol for 4 weeks prior to the study iPTH value between 150 - 1500 within the past 3 months Ca < 10.5 PO4 < 10 Exclusion Criteria: Pregnancy Intolerance to the study medication Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease) Type 1 Diabetes mellitus Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10) Hospitalization within 1 month prior to the study Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 250 ml/min) Presence of hemodialysis catheter Patients receiving steroids and/or other immunosuppressive agents (> 10 mg prednisone qd) BMI < 25 and > 45

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alp Ikizler, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

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Vitamin D, Insulin Resistance and Inflammation in ESRD

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