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TARGTEPO Treatment for Anemia in PD US Trial

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ClinicalTrials.gov Identifier: NCT02468414
Recruitment Status : Terminated (No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.)
First Posted : June 10, 2015
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Medgenics Medical Israel Ltd.
Information provided by (Responsible Party):
Aevi Genomic Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia of End Stage Renal Disease
Intervention Biological: MDGN201 TARGTEPO
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description 18-25 IU/Kg/day 35-45 IU/Kg/day
Period Title: Overall Study
Started 3 0
Successfully Screened 2 0
Harvesting 1 0
Implantation 1 0
Safety Follow-up 0 0
Completed 0 0
Not Completed 3 0
Reason Not Completed
Early Study Termination by Sponsor             1             0
Poor in-vitro secreting TARGTs             1             0
Screen Failure             1             0
Arm/Group Title Group A Group B Total
Hide Arm/Group Description TARGTEPO 18-25 IU/kg/day TARGTEPO 35-45 IU/kg/day Total of all reporting groups
Overall Number of Baseline Participants 3 0 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
<=18 years
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
3
 100.0%
0
3
 100.0%
>=65 years
0
   0.0%
0
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Female
1
  33.3%
0
1
  33.3%
Male
2
  66.7%
0
2
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
0
   0.0%
Asian
0
   0.0%
0
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
0
   0.0%
Black or African American
0
   0.0%
0
0
   0.0%
White
3
 100.0%
0
3
 100.0%
More than one race
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
0
   0.0%
1.Primary Outcome
Title Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline.
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.
Arm/Group Title Group A Group B
Hide Arm/Group Description:
TARGTEPO 18-25 IU/kg/day
TARGTEPO 35-45 IU/kg/day
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description TARGTEPO 18-25 IU/kg/day TARGTEPO 35-45 IU/kg/day
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      0/0    
Metabolism and nutrition disorders     
Hyperkalemia  1  1/2 (50.00%)  1 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/0    
Gastrointestinal disorders     
Acute Viral Gasritis  1  1/2 (50.00%)  1 0/0  0
Peritonitis  1  1/2 (50.00%)  1 0/0  0
Skin and subcutaneous tissue disorders     
Local Contact Dermatitis, Right Upper Abdomen  1  1/2 (50.00%)  1 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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).
Results Point of Contact
Name/Title: Garry A. Neil, MD
Organization: Aevi Genomic Medicine
Phone: 610-254-4208
Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT02468414     History of Changes
Other Study ID Numbers: MG-EP-RF-04
First Submitted: June 4, 2015
First Posted: June 10, 2015
Results First Submitted: June 8, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017