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

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

      • Ashkelon, Israel
        • Barzili Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center
      • Nahariya, Israel
        • Medical Center of the Galilee
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Zrifin, Israel
        • Assaf Harofeh Medical Center

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:

  1. 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.
  2. Kt/V >1
  3. INR not higher than 1.2
  4. Serum albumin >3.5
  5. Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >100 ng/ml).

Exclusion Criteria:

  1. Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
  2. Subjects who receive oral anti-coagulation treatment (e.g. warfarin)
  3. 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
  4. 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.
  5. Congestive heart failure (New York Heart Association functional class III or IV).
  6. Grand mal seizures within 2 years of the screening visit.
  7. Clinical evidence of severe hyperparathyroidism as defined by PTH levels of > 10 times the upper normal limits.
  8. Major surgery within 12 weeks of the screening visit.
  9. Systemic hematologic diseases (e.g., sickle cell anemia, thalassemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
  10. Current systemic infection, active inflammatory disease, or malignancy under active treatment.
  11. Subjects known to have tested positive at any time in the past for antibodies to erythropoietic proteins.
  12. Subject has history of malignancy within the past 2 years prior to the screening visit, with the exception of basal cell carcinoma.
  13. 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).
  14. 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.
  15. Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
  16. Female subjects of child-bearing potential and males that do not agree to use acceptable methods of contraception during the study.
  17. Pregnant and lactating female subjects.
  18. Chronic alcoholic or drug abuse subjects.
  19. Steroid or other immunosuppressive treatment (other than topical or inhaled steroids).
  20. Subjects unwilling or unable to comply with the study procedures.
  21. EPO Naïve subjects.
  22. Known sensitivity to Gentamycin and Amphotericin
  23. 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.
  24. Subject had blood transfusion within 84 days prior to Screening visit.
  25. Subject has a date for renal transplantation.
  26. Subject has a temporary or permanent hemodialysis catheter, unless: Subject has a permanent hemodialysis catheter over 6 months without signs/events of line sepsis.
  27. 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)
Erythropoietin secreted by TARGTEPO transduced with MDGN201
Experimental: Group B
MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
Erythropoietin secreted by TARGTEPO transduced with MDGN201
Experimental: Group C
MDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day)
Erythropoietin secreted by TARGTEPO transduced with MDGN201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total EPO Secretion
Time Frame: up to 52 weeks
up to 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL
Time Frame: 52 weeks
52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL
Time Frame: 52 weeks
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.

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

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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