Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-22

Study Completion Date

2017-03-01

Brief Summary

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By 2030 an estimated 2 million people in the US will need dialysis or transplantation for advanced kidney failure. An even more disturbing statistic is that mortality in End Stage Renal Disease (ESRD) is six times higher than in the general Medicare population with adjustment for age, gender and ethnicity. Protein energy wasting is highly prevalent in these patients and is one of the most important determinants of their poor clinical outcome.

Despite its well-recognized occurrence, the etiology and the mechanisms leading to protein energy wasting observed in chronic hemodialysis patients cannot be attributed to any single factor. However, irrespective of the specific etiologic mechanisms, it appears that the common pathway for all the metabolic derangements is related to exaggerated protein degradation relative to protein synthesis (47).

Two well-recognized and presumably interrelated metabolic abnormalities, insulin resistance and chronic inflammation, may be the major determinants of protein catabolism in coronary heart disease (CHD) patients. There are no studies examining the effects of anti-inflammatory interventions and/or insulin sensitizers on protein homeostasis in CHD. Due to their established anti-inflammatory and other pleiotropic effects, Interleukin-1 receptor antagonist Anakinra and insulin sensitizer peroxisome proliferator-activated receptors (PPAR) agonist Actos represent two such promising interventions. By modulating inflammatory response and insulin signaling through two pharmacological interventions, the investigators will have the unique opportunity to clarify mechanisms contributing of these two particular metabolic derangements in the development of protein energy wasting observed in chronic hemodialysis patients.

The overall goal is to elucidate the mechanisms by which chronic inflammation and insulin resistance influence the development of protein energy wasting in hemodialysis patients.

Specific Aim: To test the hypothesis that inhibiting inflammatory response by administration of an Interleukin1receptor antagonist (Anakinra) or increasing insulin sensitivity by administration of a PPAR agonist (Actos) will improve net protein metabolism.

Hypothesis: The chronic inflammatory component of protein energy wasting (PEW) observed in hemodialysis patients is, at least in part, mediated by insulin resistance.

Interim analysis may be performed (no specific plan at this time).

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Detailed Description

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Conditions

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ESRD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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anakinra

100 mg of Anakinra in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months

Group Type ACTIVE_COMPARATOR

anakinra

Intervention Type DRUG

100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)

actos

Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and 30 mg of Actos in capsules administered orally 1 capsule per day for 3 months

Group Type ACTIVE_COMPARATOR

actos

Intervention Type DRUG

30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)

placebo 1 and 2

Normal saline (placebo) in syringes administered subcutaneously 3 times a week for 3 months and lactose (placebo) in capsules administered orally 1 capsule per day for 3 months

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo capsules and injection

Interventions

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anakinra

100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)

Intervention Type DRUG

actos

30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)

Intervention Type DRUG

placebo

placebo capsules and injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients on CHD undergoing three time a week therapy for more than 6 months;
* Age 21 years old;
* Acceptable dialysis adequacy (spKt/V \> 1.2);
* A patent, well-functioning, arterio-venous dialysis access;
* Ability to give informed consent;
* Life expectancy greater than 6 months;
* BMI \>=20 and \<=45.

Exclusion Criteria

* Pregnancy;
* Intolerance or allergy to the study medication (including the metabolic clamp studies);
* Severe, unstable, active inflammatory disease (active infection, active connective tissue disorder), active cancer or cancer history in the prior 5 years except skin cancer, AIDS-HIV, active or history of liver disease (including hepatitis B virus and hepatitis C virus);
* Hospitalization or infection within 1 month prior to the study;
* Patients receiving steroids and/or other immunosuppressive agents (Prednisone \> 5 mg/day; excluding inhaled and topical steroids);
* Diabetes Mellitus on insulin therapy;
* Previous history of tuberculosis (TB) with or without documented adequate therapy;
* Patients with recent close exposure to an individual with active TB;
* Females using oral contraceptives;
* Patients with New York Heart Association (NYHA) Class III or IV heart failure;
* Patients with a history of angina, myocardial infarction, transient ischemic attacks, or strokes within the last 6 months.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No