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

NCT02378662 | Terminated Phase 2 Results

• 1 other identifier: MG-EP-RF-03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Anemia of End Stage Renal Disease

Keywords

Peritoneal Dialysis; End Stage Renal Disease; Anemia

Outcome Measures

Primary Outcomes (1)

• Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline

  52 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Biological: MDGN201 TARGTEPO

Group B

EXPERIMENTAL

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

Biological: MDGN201 TARGTEPO

Interventions

MDGN201 TARGTEPO BIOLOGICAL

MDGN201 TARGTEPO secreting EPO

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Kt/V \>1.
• INR ≤1.2
• Serum albumin \>3.2
• Subjects with adequate iron stores (transferrin saturation \> 20.0% and/or ferritin \>100 ng/ml).

You may not qualify if:

• 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 Harvest or Implantation procedure
• 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 (excluding Thalassemia minor), 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.

Sponsors & Collaborators

• Aevi Genomic Medicine, LLC, a Cerecor company: lead
• Medgenics Medical Israel Ltd.: collaborator

Study Sites (2)

Barzili Medical Center

Ashkelon, Israel

Location

Assaf Harofeh Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Garry A. Neil, MD
• Organization: Aevi Genomic Medicine

garry.neil@aevigenomics.com

610-254-4208

Study Officials

• Shany Blum, MD PhD

  Medgenics Medical Israel Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2015
• First Posted: March 4, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)