Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting

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

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD).

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Detailed Description

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This is a randomized (participants will be assigned by chance to study treatments), double-blind (participants and study personnel will not know the identity of the study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in patients who receive maintenance hemodialysis. Three participants will receive PINTA 745 for every participant that receives placebo. PINTA 745 or placebo will be taken intravenously once per week following dialysis.

The study period will consist of screening, treatment for 12 weeks, and follow up for 8 weeks. Evaluations will be performed to assess the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body) and effectiveness in treating protein energy wasting (such as increasing muscle size and muscle function) throughout the study.

Conditions

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End Stage Renal Disease Kidney Disease Protein Energy Wasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PINTA 745

Group Type EXPERIMENTAL

PINTA 745

Intervention Type DRUG

PINTA 745 will be administered once weekly by IV infusion.

Cohort dose schedules:

* 3mg/kg weekly for 12 weeks
* 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
* 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered once weekly by IV infusion.

Cohort dose schedules:

* 3mg/kg weekly for 12 weeks
* 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
* 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks

Interventions

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PINTA 745

PINTA 745 will be administered once weekly by IV infusion.

Cohort dose schedules:

* 3mg/kg weekly for 12 weeks
* 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
* 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks

Intervention Type DRUG

Placebo

Placebo will be administered once weekly by IV infusion.

Cohort dose schedules:

* 3mg/kg weekly for 12 weeks
* 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
* 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ESRD patient and on outpatient maintenance hemodialysis for ≥ 6 months
* Adequate dialysis with Kt/V ≥ 1.2 on two occasions within 12 weeks of enrollment
* Undergoing dialysis at least 3 times per week, on average
* Serum albumin ≤ 3.8g/dL within 60 days of enrollment
* Able and willing to provide Informed consent

Exclusion Criteria

* Presence of an indwelling central vascular catheter
* Current medical condition that would interfere with ability to perform physical function tests
* Active infection requiring hospitalization or antibiotics within the past month
* Major surgery within past 3 months, minor surgery within the past 4 months
* Dialysis access revision/angioplasty/replacement within the past 2 weeks
* History of renal transplant, whether or not functional, within 2 years (however, if graft has been removed, patient will be considered eligible) or plans to undergo renal transplantation within 6 months
* History of neoplasia, except non-melanoma skin cancers, with a 30% probability of recurrence within 12 months
* Current treatment with appetite stimulants, anabolic steroids or growth hormone
* Clinically significant heart disease
* Difficulty swallowing food or liquid
* If female, currently breast feeding
* If female, pregnant
* If female or male, unwilling to use a highly effective method of contraception

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No