TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)
Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) Dialysis Patients Using MDGN201 TARGTEPO
1 other identifier
interventional
11
1 country
5
Brief Summary
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2014
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedStudy Start
First participant enrolled
May 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2017
CompletedResults Posted
Study results publicly available
October 30, 2018
CompletedOctober 30, 2018
February 1, 2018
2.1 years
April 16, 2014
July 20, 2017
February 15, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Total EPO Secretion
up to 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL
52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL
Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d.
52 weeks
Study Arms (3)
Group A
EXPERIMENTALMDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)
Group B
EXPERIMENTALMDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
Group C
EXPERIMENTALMDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day)
Interventions
Erythropoietin secreted by TARGTEPO transduced with MDGN201
Eligibility Criteria
You may qualify if:
- For ESRD patients: Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on hemodialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL.
- Kt/V \>1
- INR not higher than 1.2
- Serum albumin \>3.5
- Subjects with adequate iron stores (transferrin saturation \> 20.0% and/or ferritin \>100 ng/ml).
You may not qualify if:
- Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
- Subjects who receive oral anti-coagulation treatment (e.g. warfarin)
- Subjects who receive Acetyl Salicylic Acid (ASA) above 325 mg/day or patients who receive ASA treatment between 100mg/d and 325 mg/d who cannot discontinue it for 1 week prior to each EPODURE procedure
- Congestive heart failure (New York Heart Association functional class III or IV).
- Grand mal seizures within 2 years of the screening visit.
- Clinical evidence of severe hyperparathyroidism as defined by PTH levels of \> 10 times the upper normal limits.
- Major surgery within 12 weeks of the screening visit.
- Systemic hematologic diseases (e.g., sickle cell anemia, thalassemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
- Current systemic infection, active inflammatory disease, or malignancy under active treatment.
- Subjects known to have tested positive at any time in the past for antibodies to erythropoietic proteins.
- Subject has history of malignancy within the past 2 years prior to the screening visit, with the exception of basal cell carcinoma.
- Subjects with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, uncompensated cirrhosis, active upper GI tract ulceration).
- Subject is currently enrolled in, or has not yet completed a period of at least 30 days or five half-lives of the investigational drug whichever is longer, since ending other investigational device or drug trial(s) prior to Screening phase.
- Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
- Female subjects of child-bearing potential and males that do not agree to use acceptable methods of contraception during the study.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Barzili Medical Center
Ashkelon, Israel
Meir Medical Center
Kfar Saba, Israel
Medical Center of the Galilee
Nahariya, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Assaf Harofeh Medical Center
Zrifin, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Garry A Neil
- Organization
- Aevi Genomic Medicine
Study Officials
- STUDY DIRECTOR
Shany Blum, MD PhD
Aevi Genomic Medicine, LLC, a Cerecor company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2014
First Posted
April 21, 2014
Study Start
May 27, 2014
Primary Completion
June 30, 2016
Study Completion
March 20, 2017
Last Updated
October 30, 2018
Results First Posted
October 30, 2018
Record last verified: 2018-02