Trial Outcomes & Findings for TARGTEPO Treatment for Anemia in PD US Trial (NCT NCT02468414)
NCT ID: NCT02468414
Last Updated: 2022-03-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
52 weeks
Results posted on
2022-03-28
Participant Flow
Participant milestones
| Measure |
Group A
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
Successfully Screened
|
2
|
0
|
|
Overall Study
Harvesting
|
1
|
0
|
|
Overall Study
Implantation
|
1
|
0
|
|
Overall Study
Safety Follow-up
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group A
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
|---|---|---|
|
Overall Study
Early Study Termination by Sponsor
|
1
|
0
|
|
Overall Study
Poor in-vitro secreting TARGTs
|
1
|
0
|
|
Overall Study
Screen Failure
|
1
|
0
|
Baseline Characteristics
TARGTEPO Treatment for Anemia in PD US Trial
Baseline characteristics by cohort
| Measure |
Group A
n=3 Participants
TARGTEPO 18-25 IU/kg/day
|
Group B
TARGTEPO 35-45 IU/kg/day
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.
Outcome measures
| Measure |
Group A
n=1 Participants
TARGTEPO 18-25 IU/kg/day
|
Group B
TARGTEPO 35-45 IU/kg/day
|
|---|---|---|
|
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline.
|
1 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=2 participants at risk
TARGTEPO 18-25 IU/kg/day
|
Group B
TARGTEPO 35-45 IU/kg/day
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
Other adverse events
| Measure |
Group A
n=2 participants at risk
TARGTEPO 18-25 IU/kg/day
|
Group B
TARGTEPO 35-45 IU/kg/day
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Local Contact Dermatitis, Right Upper Abdomen
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Acute Viral Gasritis
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Peritonitis
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should the Primary Investigator (PI) wish to publish the results of this study, the PI agrees to provide the Sponsor with a manuscript for review 60 days prior to submission for publication. The Sponsor retains the right to delete from the manuscript information that is confidential and proprietary and to object to suggested publication and/or its timing (at the Sponsor's sole discretion).
- Publication restrictions are in place
Restriction type: OTHER