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

NCT01958970 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-04-11

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Pinta Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Christopher Haqq, MD, PhD · Pinta Biotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958970 on ClinicalTrials.gov