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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pinta Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Pinta Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01958970
First received: October 7, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
End Stage Renal Disease
Kidney Disease
Protein Energy Wasting
Drug: PINTA 745
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pinta Biotherapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline through Week 20 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline through Week 20 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958970

Contacts
Contact: Esther Welkowsky ewelkowsky@atarabio.com
Contact: Christopher Haqq, MD, PhD chaqq@atarabio.com

Locations
United States, Colorado
DaVita Clinical Research Recruiting
Lakewood, Colorado, United States, 80228
Contact: Marla Elhard    303-566-3005    marla.elhard@davita.com   
Principal Investigator: Galloway, MD         
United States, Florida
Orlando Clinical Research Center Recruiting
Orlando, Florida, United States, 32809
Contact: Derek Bell    407-240-7876    dbell@ocrc.net   
Principal Investigator: Marbury, MD         
United States, Minnesota
DaVita Clinical Research Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Colleen Herbranson    612-852-7002    colleen.herbranson@davita.com   
Principal Investigator: Berg, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Brigitta Brannon    615-343-1218    brigitta.brannon@vanderbilt.edu   
Principal Investigator: Ikizler, MD         
United States, Texas
Clinical Advancement Center, PLLC Recruiting
San Antonio, Texas, United States, 78215
Contact: Letti Hudson, RN    210-223-4444    lhudson@raparesearch.com   
Principal Investigator: Pergola, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Lori Linke    206-720-3835    LLinke@Nephrology.washington.edu   
Principal Investigator: Kestenbaum, MD         
Sponsors and Collaborators
Pinta Biotherapeutics
Investigators
Study Director: Christopher Haqq, MD, PhD Pinta Biotherapeutics
  More Information

No publications provided

Responsible Party: Pinta Biotherapeutics
ClinicalTrials.gov Identifier: NCT01958970     History of Changes
Other Study ID Numbers: 745-201
Study First Received: October 7, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pinta Biotherapeutics:
End Stage Renal Disease
ESRD
Maintenance Hemodialysis
Hemodialysis
Dialysis
MHD
Protein Energy Wasting
PEW

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Cachexia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014