Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting
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).
End Stage Renal Disease
Protein Energy Wasting
Drug: PINTA 745
|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|
- 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)
- 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 16 and 20 weeks. To evaluate change relative to baseline in MUAMC at 12, 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
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: PINTA 745||
Drug: PINTA 745
PINTA 745 will be administered once weekly by IV infusion at a dose of 3mg/kg or 10mg/kg.
|Placebo Comparator: Placebo||
Placebo will be administered once weekly by IV infusion at a dose of 3mg/kg or 10mg/kg.
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 (starting at 3 mg/kg up to a maximum of 10 mg/kg) 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.
|Contact: Esther Welkowskyemail@example.com|
|Contact: Christopher Haqq, MD, PhDfirstname.lastname@example.org|
|United States, Florida|
|Orlando Clinical Research Center||Recruiting|
|Orlando, Florida, United States, 32809|
|Contact: Derek Bell 407-240-7876 email@example.com|
|Principal Investigator: Marbury, MD|
|United States, Minnesota|
|DaVita Clinical Research||Recruiting|
|Minneapolis, Minnesota, United States, 55404|
|Contact: Colleen Herbranson 612-852-7002 firstname.lastname@example.org|
|Principal Investigator: Berg, MD|
|United States, Tennessee|
|Vanderbilt University Medical Center||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Brigitta Brannon 615-343-1218 email@example.com|
|Principal Investigator: Ikizler, MD|
|United States, Washington|
|University of Washington||Not yet recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Lori Linke 206-720-3835 LLinke@Nephrology.washington.edu|
|Principal Investigator: Kestenbaum, MD|
|Study Director:||Christopher Haqq, MD, PhD||Pinta Biotherapeutics|