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TARGTEPO Treatment for Anemia in PD US Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468414
Recruitment Status : Terminated (No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.)
First Posted : June 10, 2015
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Medgenics Medical Israel Ltd.
Information provided by (Responsible Party):
Aevi Genomic Medicine, LLC, a Cerecor company

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

Condition or disease Intervention/treatment Phase
Anemia of End Stage Renal Disease Biological: MDGN201 TARGTEPO Phase 2

Detailed Description:

This is a Phase II, open-label study. Each patient will be administered with a targeted dose of 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety & Efficacy of Prolonged Physiologic EPO Level Treatment of Anemia in ESRD Patients Undergoing Peritoneal Dialysis Using MDGN201 TARGTEPO
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: MDGN201 TARGTEPO secreting EPO
MDGN201 TARGTEPO secreting EPO
Biological: MDGN201 TARGTEPO
MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)

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




Primary Outcome Measures :
  1. Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline. [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male or female subjects between 18 to 80 years of age at the time of screening visit.
  2. Subject diagnosed with anemia due to Chronic Kidney Disease (CKD) Stage 5 on peritoneal dialysis treatment for at least 6 months. Average Hgb during last month between 9 to 12g/dL. Stable dose of ESAs over the past month prior to enrollment.
  3. Hypertensive subjects are stable on anti HTN treatment for the past one month prior to enrollment and has Systolic blood pressure (BP) below 150 and Diastolic BP below 90 upon enrollment.
  4. Kt/V > 1.
  5. INR ≤ 1.2.
  6. Serum albumin > 3.2.
  7. Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >100 ng/ml).
  8. Capable of providing signed written informed consent to participate in the study.

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 acetylsalicylic 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 parathyroid hormone (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 that 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 gastrointestinal (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 or 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 gentamicin and amphotericin.
  22. History of chronic or active hepatitis B and/or C infection or positive serology at screening, and known positive Human Immunodeficiency Virus (HIV) or positive serology at screening.
  23. Subject had a blood transfusion within 84 days prior to Screening Visit.
  24. Subject has a date for renal transplantation.
  25. Refer to the United States Product Insert (USPI) - Depo-Medrol (DM) - Methylprednisolone Acetate - Injectable (Appendix A) for any concomitant drug taken by the patient, which its interactions with DM will warrant exclusion from this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468414


Locations
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United States, Texas
Clinical Advancement Center, PLLC
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Aevi Genomic Medicine, LLC, a Cerecor company
Medgenics Medical Israel Ltd.
Investigators
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Study Chair: Shany Blum, MD PhD Medgenics Medical Israel Ltd.
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Responsible Party: Aevi Genomic Medicine, LLC, a Cerecor company
ClinicalTrials.gov Identifier: NCT02468414    
Other Study ID Numbers: MG-EP-RF-04
First Posted: June 10, 2015    Key Record Dates
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Early stage small feasibility study.
Keywords provided by Aevi Genomic Medicine, LLC, a Cerecor company:
Peritoneal Dialysis
End Stage Renal Disease
Anemia
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency