AnemiaPhase 1/2NCT00542568
Safety and Efficacy of Sustained Erythropoietin Therapy
A Phase 1/2 study testing EPODURE (dermal Biopump for erythropoietin) in people with Anemia, run by Medgenics Medical Israel Ltd. at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia
- What is being tested?
- EPODURE (dermal Biopump for erythropoietin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2008to Jan 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Organization
Jerusalem
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients Using EPODURE Biopump
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- EPODURE (dermal Biopump for erythropoietin)
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPODURE (dermal Biopump for erythropoietin)Biological
Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cohort 1 (Low Dose group) 18-25 IU/kg/day Receives: Biological: EPODURE (dermal Biopump for erythropoietin) |
| 2 | Experimental | Cohort 2 (Intermediate Dose group): 35-45 IU/kg/day Receives: Biological: EPODURE (dermal Biopump for erythropoietin) |
| 3 | Experimental | Cohort 3 (High Dose group): 55-65 IU/kg/day Receives: Biological: EPODURE (dermal Biopump for erythropoietin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints: adverse events; safety laboratory values; immune response by determination of anti-EPO antibodies; dermal safety outcomes
Measured: 6 weeks and 6 months
Secondary outcomes (1)
Elevation of serum EPO levels at least 10 mU/ml above baseline for duration of at least six (6) weeks following implantation
Measured: 6 weeks and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startAug 2008
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medgenics Medical Israel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Eithan Galun, M.D, Principal investigator, Hadassah Medical OrganizationDoron Schwartz, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542568
- Sponsor's protocol ID
- MG-001-02
- Status last verified
- Apr 2014
- First submitted
- 10 Oct 2007
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients Using EPODURE Biopump
- ClinicalTrials.gov ID
- NCT00542568
- Acronym / sponsor ID
- MG-001-02
- Conditions
- Anemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medgenics Medical Israel Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: EPODURE (dermal Biopump for erythropoietin)Cohort 1 (Low Dose group) 18-25 IU/kg/day |
| 2 | Experimental | Biological: EPODURE (dermal Biopump for erythropoietin)Cohort 2 (Intermediate Dose group): 35-45 IU/kg/day |
| 3 | Experimental | Biological: EPODURE (dermal Biopump for erythropoietin)Cohort 3 (High Dose group): 55-65 IU/kg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPODURE (dermal Biopump for erythropoietin)Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump | Biological | 1, 2, 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Eithan Galun, M.D principal investigator
Hadassah Medical Organization
Doron Schwartz, MD principal investigator
Tel-Aviv Sourasky Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EPODURE (dermal Biopump for erythropoietin) in people with Anemia, run by Medgenics Medical Israel Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.