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

NCT01958970 | Completed Phase 1

• 1 other identifier: 745-201
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 6

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).

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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 (2)

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

  Baseline through Week 20

• Change in Physical Function

  Baseline through Week 20

Study Arms (2)

PINTA 745

EXPERIMENTAL

Drug: PINTA 745

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PINTA 745 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

PINTA 745

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pinta Biotherapeutics: lead

Study Sites (6)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78215, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Haqq, MD, PhD

  Pinta Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

US (6)