- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117427
TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)
February 15, 2018 updated by: Aevi Genomic Medicine, LLC, a Cerecor company
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
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase I-II, open-label study.
Each patient will receive targeted dose of EPO delivered via TARGTEPO.
The targeted doses will be determined according to 3 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day), Group C (55-65 IU/Kg/day).
The objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining Hb levels within the target range of 9-12 g/dl.
Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ashkelon, Israel
- Barzili Medical Center
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Kfar Saba, Israel
- Meir Medical Center
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Nahariya, Israel
- Medical Center of the Galilee
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
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Zrifin, Israel
- Assaf Harofeh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- Patients currently receiving injections of long-acting Erythropoiesis Stimulating Agents (ESA) (e.g. Aranesp, Mircera), a patient on long acting ESA can be switched to a short acting preparation (e.g Eprex) and enroll in the study after meeting the inclusion criteria and not meeting any other exclusion criteria.
- 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.
- Pregnant and lactating female subjects.
- Chronic alcoholic or drug abuse subjects.
- Steroid or other immunosuppressive treatment (other than topical or inhaled steroids).
- Subjects unwilling or unable to comply with the study procedures.
- EPO Naïve subjects.
- Known sensitivity to Gentamycin and Amphotericin
- History of chronic or active Hepatitis B and/or C infection or positive serology at screening and known positive HIV or positive serology at screening.
- Subject had blood transfusion within 84 days prior to Screening visit.
- Subject has a date for renal transplantation.
- Subject has a temporary or permanent hemodialysis catheter, unless: Subject has a permanent hemodialysis catheter over 6 months without signs/events of line sepsis.
- Refer to the USPI - Depo-Medrol - Methylprednisolone Acetate - Injectable (Appendix A) for any concomitant drug taken by the patient which its interaction with Depo-Medrol will warrant exclusion from this protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)
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Erythropoietin secreted by TARGTEPO transduced with MDGN201
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Experimental: Group B
MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
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Erythropoietin secreted by TARGTEPO transduced with MDGN201
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Experimental: Group C
MDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day)
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Erythropoietin secreted by TARGTEPO transduced with MDGN201
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total EPO Secretion
Time Frame: up to 52 weeks
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up to 52 weeks
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Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL
Time Frame: 52 weeks
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52 weeks
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Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL
Time Frame: 52 weeks
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Shany Blum, MD PhD, Aevi Genomic Medicine, LLC, a Cerecor company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2014
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
March 20, 2017
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Actual)
October 30, 2018
Last Update Submitted That Met QC Criteria
February 15, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MG-EP-RF-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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