Trial Outcomes & Findings for TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD) (NCT NCT02378662)
NCT ID: NCT02378662
Last Updated: 2018-10-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
52 weeks
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
Group A
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
Harvesting
|
2
|
0
|
|
Overall Study
Implantation
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group A
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
|---|---|---|
|
Overall Study
Early Discontinuation
|
2
|
0
|
Baseline Characteristics
TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)
Baseline characteristics by cohort
| Measure |
Group A
n=2 Participants
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
Total
n=2 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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 two subjects were treated with MDGN201 TARGTEPO due to Sponsor's decision to discontinue study.
Outcome measures
| Measure |
Group A
n=2 Participants
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
|---|---|---|
|
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline
|
2 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 0 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
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=2 participants at risk
18-25 IU/Kg/day
|
Group B
35-45 IU/Kg/day
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intermittent Muscle cramps in both legs
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Infections and infestations
Catheter exit site infection
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Immune system disorders
Allergic reaction to ciprofloxacin
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Swelling in right groin
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Redness in right groin
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should the investigator wish to publish the results of this study, the investigator agrees to provide Medgenics with a manuscript for review 60 days prior to submission for publication. Medgenics 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 Company's sole discretion).
- Publication restrictions are in place
Restriction type: OTHER