| Trial ID: | L1421 |
| Source ID: | NCT01958970
|
| Associated Drug: |
Pinta 745
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| Title: |
Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
End Stage Renal Disease|Kidney Disease|Protein Energy Wasting
|
| Interventions: |
DRUG: PINTA 745|DRUG: Placebo
|
| Outcome Measures: |
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|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
|
| Sponsor/Collaborators: |
Sponsor: Pinta Biotherapeutics
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
51
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
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| Completion Date: |
2016-01
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| Results First Posted: |
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| Last Update Posted: |
2018-04-11
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| Locations: |
DaVita Clinical Research, Lakewood, Colorado, 80228, United States|Orlando Clinical Research Center, Orlando, Florida, 32809, United States|DaVita Clinical Research, Minneapolis, Minnesota, 55404, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78215, United States|University of Washington, Seattle, Washington, 98104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01958970
|
