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

Primary Purpose

End Stage Renal Disease, Kidney Disease, Protein Energy Wasting

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PINTA 745
Placebo
Sponsored by
Pinta Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End Stage Renal Disease, ESRD, Maintenance Hemodialysis, Hemodialysis, Dialysis, MHD, Protein Energy Wasting, PEW

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DaVita Clinical Research
  • Orlando Clinical Research Center
  • DaVita Clinical Research
  • Vanderbilt University Medical Center
  • Clinical Advancement Center, PLLC
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PINTA 745

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM)
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

Change in Muscle Composition - Lean Body Mass (LBM), Appendicular Lean Mass (ALM) and Mid Upper Arm Muscle Circumference (MUAMC)
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.
Change in Physical Function
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

Full Information

First Posted
October 7, 2013
Last Updated
April 10, 2018
Sponsor
Pinta Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01958970
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pinta Biotherapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Kidney Disease, Protein Energy Wasting
Keywords
End Stage Renal Disease, ESRD, Maintenance Hemodialysis, Hemodialysis, Dialysis, MHD, Protein Energy Wasting, PEW

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PINTA 745
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PINTA 745
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM)
Description
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)
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
Secondary Outcome Measure Information:
Title
Change in Muscle Composition - Lean Body Mass (LBM), Appendicular Lean Mass (ALM) and Mid Upper Arm Muscle Circumference (MUAMC)
Description
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.
Time Frame
Baseline through Week 20
Title
Change in Physical Function
Description
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
Time Frame
Baseline through Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Haqq, MD, PhD
Organizational Affiliation
Pinta Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
DaVita Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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