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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958970
• Other study ID #: 745-201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 7, 2013
• Last updated: April 10, 2018
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2018
• Source: Pinta Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• End Stage Renal Disease
• Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Protein Energy Wasting

Intervention

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
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

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Lakewood	Colorado
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pinta Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline through Week 20
Secondary	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	Baseline through Week 20