TARGTEPO Treatment for Anemia in PD US Trial

NCT02468414 | Terminated Phase 2 Results DMC

• 1 other identifier: MG-EP-RF-04
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 EPO Levels Above Baseline.

  52 weeks

Study Arms (1)

MDGN201 TARGTEPO secreting EPO

EXPERIMENTAL

MDGN201 TARGTEPO secreting EPO

Biological: MDGN201 TARGTEPO

Interventions

MDGN201 TARGTEPO BIOLOGICAL

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

MDGN201 TARGTEPO secreting EPO

Eligibility Criteria

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

You may qualify if:

• Adult male or female subjects between 18 to 80 years of age at the time of screening visit.
• 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.
• 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.
• 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).
• Capable of providing signed written informed consent to participate in the study.

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 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.
• 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 parathyroid hormone (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 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).
• 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 (1)

Clinical Advancement Center, PLLC

San Antonio, Texas, 78215, United States

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 CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 10, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 28, 2022
• Results First Posted: July 13, 2017

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)