Safety and Efficacy of Sustained Erythropoietin Therapy
Primary Purpose
Anemia
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
EPODURE (dermal Biopump for erythropoietin)
Sponsored by

About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Adult male or female subjects between 18 to 75 years of age at the time of screening visit.
- Subject with Anemia of Chronic Renal Failure CKD stage 3-4. estimated GFR of 15-60 ml/min with Female: Hb < 10 g%, Male: Hb < 11 g%.
- Chronic renal failure subjects who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than four (4) weeks.
- Subjects who are clinically stable.
- Adequate iron stores (transferrin saturation ≥ 20.0% and ferritin ≥100 ng/ml).
- Subjects who receive anti-coagulation treatment may be enrolled provided anti-coagulation treatment can be discontinued two weeks prior to the harvesting visit. INR level must be within normal range (0.9 - 1.5).
Signed written informed consent to participate in the study by subject
Exclusion Criteria:
- Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
- 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, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
- Current systemic infection, active inflammatory disease, or malignancy under treatment.
- Known positivity for HIV antibody.
- 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 cardiac 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 since ending other investigational device or drug trial(s).
- Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study.
- Female subjects of child-bearing potential and not having undergone permanent sterilization procedures.
- Pregnant and lactating female subjects.
- Chronic alcoholic or drug abuse subjects.
- Steroid or other immunosuppressive treatment.
- Subjects unwilling or unable to comply with the study procedures.
Sites / Locations
- Hadassah Medical Organization
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Cohort 1 (Low Dose group) 18-25 IU/kg/day
Cohort 2 (Intermediate Dose group): 35-45 IU/kg/day
Cohort 3 (High Dose group): 55-65 IU/kg/day
Outcomes
Primary Outcome Measures
Safety Endpoints: adverse events; safety laboratory values; immune response by determination of anti-EPO antibodies; dermal safety outcomes
Secondary Outcome Measures
Elevation of serum EPO levels at least 10 mU/ml above baseline for duration of at least six (6) weeks following implantation
Full Information
NCT ID
NCT00542568
First Posted
October 10, 2007
Last Updated
April 16, 2014
Sponsor
Medgenics Medical Israel Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00542568
Brief Title
Safety and Efficacy of Sustained Erythropoietin Therapy
Official Title
Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients Using EPODURE Biopump
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medgenics Medical Israel Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purposes of this study are to assess safety, efficacy, and subject satisfaction of EPODURE Biopump (an autologous dermal biopump capable of sustained secretion of therapeutic EPO in the body, using a small tissue explant from the patient's own skin) treatment in Chronic Kidney Disease (CKD) patients over a period of up to six (6) months.
Detailed Description
Anemia, is a common complication of chronic kidney disease (CKD) resulting from insufficient production of the hormone erythropoietin by the damaged kidney leading to a decrease in red blood cells production by the bone marrow.
Replacement therapy with recombinant human erythropoietin can effectively correct anemia in patients. However, despite the availability of recombinant human erythropoietin for more than a decade for use in CKD patients, two thirds of patients initiating dialysis have a hematocrit less than 30%, and three fourths have a hemoglobin (Hb) less than 11 g/dL the level recommended by the National Kidney Foundation Kidney Disease Outcome Quality Initiative. Treatment with recombinant human erythropoietin typically involves subcutaneous (SC) administration at regular intervals followed by frequent laboratory tests to monitor hemoglobin concentration. There is a need to provide an significantly improved care in this area using a sustained therapy approach.
EPODURE, is an autologous dermal biopump capable of sustained secretion of therapeutic EPO in the body, using a small tissue explant from the patient's own skin. The EPODURE biopump is harvested directly from the patient's dermis under local anesthetic. EPODURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral EPO vectors (HDAd-EPO), expresses and secretes EPO. The EPODURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of EPO.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cohort 1 (Low Dose group) 18-25 IU/kg/day
Arm Title
2
Arm Type
Experimental
Arm Description
Cohort 2 (Intermediate Dose group): 35-45 IU/kg/day
Arm Title
3
Arm Type
Experimental
Arm Description
Cohort 3 (High Dose group): 55-65 IU/kg/day
Intervention Type
Biological
Intervention Name(s)
EPODURE (dermal Biopump for erythropoietin)
Intervention Description
Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump
Primary Outcome Measure Information:
Title
Safety Endpoints: adverse events; safety laboratory values; immune response by determination of anti-EPO antibodies; dermal safety outcomes
Time Frame
6 weeks and 6 months
Secondary Outcome Measure Information:
Title
Elevation of serum EPO levels at least 10 mU/ml above baseline for duration of at least six (6) weeks following implantation
Time Frame
6 weeks and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female subjects between 18 to 75 years of age at the time of screening visit.
Subject with Anemia of Chronic Renal Failure CKD stage 3-4. estimated GFR of 15-60 ml/min with Female: Hb < 10 g%, Male: Hb < 11 g%.
Chronic renal failure subjects who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than four (4) weeks.
Subjects who are clinically stable.
Adequate iron stores (transferrin saturation ≥ 20.0% and ferritin ≥100 ng/ml).
Subjects who receive anti-coagulation treatment may be enrolled provided anti-coagulation treatment can be discontinued two weeks prior to the harvesting visit. INR level must be within normal range (0.9 - 1.5).
Signed written informed consent to participate in the study by subject
Exclusion Criteria:
Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
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, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
Current systemic infection, active inflammatory disease, or malignancy under treatment.
Known positivity for HIV antibody.
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 cardiac 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 since ending other investigational device or drug trial(s).
Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study.
Female subjects of child-bearing potential and not having undergone permanent sterilization procedures.
Pregnant and lactating female subjects.
Chronic alcoholic or drug abuse subjects.
Steroid or other immunosuppressive treatment.
Subjects unwilling or unable to comply with the study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Eithan Galun, M.D
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doron Schwartz, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Sustained Erythropoietin Therapy
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