Clinical trial NCT01958970: Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting
Official title: A Randomized, Double-blind, Pilot Study of PINTA 745, an Anti-myostatin Peptibody, in Patients With End Stage Renal Disease Who Require Maintenance Hemodialysis and Have Protein Energy Wasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease
Kidney Disease
Protein Energy Wasting
Keywords: End Stage Renal Disease
ESRD
Maintenance Hemodialysis
Hemodialysis
Dialysis
MHD
Protein Energy Wasting
PEW
Lead sponsor: Pinta Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM)
timeFrame: MTD will be assessed after the last patient in Cohort 1A and Cohort 2A complete 28 days on treatment. LBM will be assessed for comparing baseline to Week 12
Secondary outcomes:
measure: Change in Muscle Composition - Lean Body Mass (LBM), Appendicular Lean Mass (ALM) and Mid Upper Arm Muscle Circumference (MUAMC)
timeFrame: Baseline through Week 20
measure: Change in Physical Function
timeFrame: Baseline through Week 20
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Pinta Biotherapeutics
name: Christopher Haqq, MD, PhD
role: STUDY_DIRECTOR
References: