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
Sponsored by
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
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
Active Comparator
Arm Label
1
2
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
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
No
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
1
Arm Type
Active Comparator
Arm Description
SOC medication for treatment of renal osteodystrophy
Arm Title
2
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
No
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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