TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-27

Study Completion Date

2017-03-20

Brief Summary

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The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.

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Detailed Description

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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

Conditions

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Chronic Kidney Disease End Stage Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)

Group Type EXPERIMENTAL

MDGN201 TARGTEPO

Intervention Type BIOLOGICAL

Erythropoietin secreted by TARGTEPO transduced with MDGN201

Group B

MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)

Group Type EXPERIMENTAL

MDGN201 TARGTEPO

Intervention Type BIOLOGICAL

Erythropoietin secreted by TARGTEPO transduced with MDGN201

Group C

MDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day)

Group Type EXPERIMENTAL

MDGN201 TARGTEPO

Intervention Type BIOLOGICAL

Erythropoietin secreted by TARGTEPO transduced with MDGN201

Interventions

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MDGN201 TARGTEPO

Erythropoietin secreted by TARGTEPO transduced with MDGN201

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No