Vitamin D, Insulin Resistance and Inflammation in ESRD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

SOC medication for treatment of renal osteodystrophy

Group Type ACTIVE_COMPARATOR

paricalcitol

Intervention Type OTHER

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

2

alternate SOC medication for treatment of renal osteodystrophy

Group Type ACTIVE_COMPARATOR

cinacalcet

Intervention Type OTHER

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

Interventions

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paricalcitol

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

Intervention Type OTHER

cinacalcet

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

Intervention Type OTHER

Other Intervention Names

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zemplar sensipar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No