- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378662
TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)
Safety & Efficacy of Prolonged Physiologic Erythropoietin (EPO) Level Treatment of Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)Using MDGN201 TARGTEPO
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Ashkelon, Israel
- Barzili Medical Center
-
Zrifin, Israel
- Assaf Harofeh Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- Pregnant and lactating female subjects.
- Chronic alcoholic or drug abuse subjects.
- Steroid or other immunosuppressive treatment (other than topical or inhaled steroids).
- Subjects unwilling or unable to comply with the study procedures.
- EPO Naïve subjects.
- Known sensitivity to Gentamycin and Amphotericin
- 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.
- Subject had blood transfusion within 84 days prior to Screening visit.
- Subject has a date for renal transplantation.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)
|
MDGN201 TARGTEPO secreting EPO
|
Experimental: Group B
MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
|
MDGN201 TARGTEPO secreting EPO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Shany Blum, MD PhD, Medgenics Medical Israel Ltd.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MG-EP-RF-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia of End Stage Renal Disease
-
Aevi Genomic Medicine, LLC, a Cerecor companyMedgenics Medical Israel Ltd.Terminated
-
Hamad Medical CorporationCompleted
-
University of LouisvilleNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedAnemia of End Stage Renal DiseaseUnited States
-
CinnagenCompletedAnemia in End-Stage Renal DiseaseIran, Islamic Republic of
-
FibroGenAstraZenecaCompletedAnemia Associated With End Stage Renal DiseaseUnited States
-
FibroGenAstraZenecaCompletedAnemia Associated With End Stage Renal Disease (ESRD)United States
-
FibroGenPeking University First Hospital; Peking Union Medical College Hospital; First... and other collaboratorsCompletedAnemia in End Stage Renal DiseaseChina
-
Astellas Pharma Europe B.V.FibroGenCompletedAnemia | End Stage Renal Disease (ESRD)Bulgaria, Croatia, Czechia, Germany, Hungary, Poland, Russian Federation, Serbia, Spain, United Kingdom, Belgium, France, Georgia, Italy, Portugal, Romania, Slovakia
-
Nanyang Technological UniversityNational Kidney Foundation, SingaporeRecruitingEnd Stage Renal Disease | End Stage Kidney Disease | End Stage Renal Failure on Dialysis | End Stage Renal Disease on DialysisSingapore
-
SandozHexal AGCompletedChronic Kidney Disease | End-stage Renal Disease | AnaemiaAustria, France, Germany, Italy, Poland, Romania, Slovenia, Spain, Switzerland, United Kingdom
Clinical Trials on MDGN201 TARGTEPO
-
Aevi Genomic Medicine, LLC, a Cerecor companyMedgenics Medical Israel Ltd.Terminated
-
Aevi Genomic Medicine, LLC, a Cerecor companyMedgenics Medical Israel Ltd.CompletedEnd Stage Renal Disease | Chronic Kidney DiseaseIsrael