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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01958970
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : April 11, 2018
Information provided by (Responsible Party):
Pinta Biotherapeutics

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).

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Kidney Disease Protein Energy Wasting Drug: PINTA 745 Drug: Placebo Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PINTA 745 Drug: 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

Placebo Comparator: Placebo 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

Primary Outcome Measures :
  1. Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM) [ Time Frame: 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 ]
    To evaluate the safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and pharmacokinetics of PINTA 745 and to evaluate percentage change in LBM relative to baseline at 12 weeks, via dual-energy x-ray absorptiometry(DXA) scans, in the group receiving PINTA 745 at the MTD (or if no MTD is reached, at the recommended phase 2 dose)

Secondary Outcome Measures :
  1. Change in Muscle Composition - Lean Body Mass (LBM), Appendicular Lean Mass (ALM) and Mid Upper Arm Muscle Circumference (MUAMC) [ Time Frame: Baseline through Week 20 ]
    To evaluate the change in LBM and ALM via CT and dual-energy x-ray absorptiometry (DXA) scans relative to baseline at 12, 16 and 20 weeks. To evaluate change relative to baseline in MUAMC at 5, 9, 16 and 20 weeks.

  2. Change in Physical Function [ Time Frame: Baseline through Week 20 ]
    To evaluate change in physical function as measured by the Stair Climbing Power Test (SCPT) and the 6 Minute Walk Test (6MWT) relative to baseline at 5, 9, 12, 16 and 20 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01958970

United States, Colorado
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Clinical Advancement Center, PLLC
San Antonio, Texas, United States, 78215
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Pinta Biotherapeutics
Study Director: Christopher Haqq, MD, PhD Pinta Biotherapeutics

Responsible Party: Pinta Biotherapeutics Identifier: NCT01958970     History of Changes
Other Study ID Numbers: 745-201
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Pinta Biotherapeutics:
End Stage Renal Disease
Maintenance Hemodialysis
Protein Energy Wasting

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Wasting Syndrome
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders