TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)

NCT ID: NCT02378662

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-06-30

Brief Summary

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients

Detailed Description

This is a Phase II, open-label study. Each patient will receive targeted dose of Erythropoietin (EPO) delivered via TARGTEPO.

The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 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

Anemia of End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

MDGN201 TARGTEPO

Intervention Type: BIOLOGICAL

MDGN201 TARGTEPO secreting EPO

Group B

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

Group Type: EXPERIMENTAL

MDGN201 TARGTEPO

Intervention Type: BIOLOGICAL

MDGN201 TARGTEPO secreting EPO

Interventions

MDGN201 TARGTEPO

MDGN201 TARGTEPO secreting EPO

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on peritoneal dialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL.

2. Kt/V >1.

3. INR ≤1.2

4. Serum albumin >3.2

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 Harvest or Implantation procedure

4. Congestive heart failure (New York Heart Association functional class III or IV).

5. Grand mal seizures within 2 years of the screening visit.

6. Clinical evidence of severe hyperparathyroidism as defined by PTH levels of > 10 times the upper normal limits.

7. Major surgery within 12 weeks of the screening visit.

8. Systemic hematologic diseases (e.g., sickle cell anemia, thalassemia (excluding Thalassemia minor), myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).

9. Current systemic infection, active inflammatory disease, or malignancy under active treatment.

10. Subjects known to have tested positive at any time in the past for antibodies to erythropoietic proteins.

11. Subject has history of malignancy within the past 2 years prior to the screening visit, with the exception of basal cell carcinoma.

12. 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).

13. 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.

14. Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.

15. Female subjects of child-bearing potential and males that do not agree to use acceptable methods of contraception during the study.

16. Pregnant and lactating female subjects.

17. Chronic alcoholic or drug abuse subjects.

18. Steroid or other immunosuppressive treatment (other than topical or inhaled steroids).

19. Subjects unwilling or unable to comply with the study procedures.

20. EPO Naïve subjects.

21. Known sensitivity to Gentamycin and Amphotericin

22. 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.

23. Subject had blood transfusion within 84 days prior to Screening visit.

24. Subject has a date for renal transplantation.

25. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medgenics Medical Israel Ltd.

INDUSTRY

Sponsor Role: collaborator

Aevi Genomic Medicine, LLC, a Cerecor company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shany Blum, MD PhD

Role: STUDY_DIRECTOR

Medgenics Medical Israel Ltd.

Locations

Barzili Medical Center

Ashkelon, , Israel

Assaf Harofeh Medical Center

Zrifin, , Israel

Countries

Israel

Other Identifiers

MG-EP-RF-03

Identifier Type: -

Identifier Source: org_study_id