AnemiaPhase 1/2NCT01555515
Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant
A Phase 1/2 study testing implantation of autologous skin graft after ex-vivo treatment and Subcutan implantation of autologus skin graft after ex-vivo treatment in people with Anemia and End Stage Renal Disease, run by Medgenics Medical Israel Ltd..
Trial summary
In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia, End Stage Renal Disease
- What is being tested?
- implantation of autologous skin graft after ex-vivo treatment and Subcutan implantation of autologus skin graft after ex-vivo treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2014
- 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 diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on dialysis treatment for at least 3 months. Hb < 12g/dL on 2 consecutive measures
- Kt/V >1
- INR not higher than 1.2
- Subjects who are clinically stable.
- Serum albumin > 3.5
- Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin > 100 ng/ml).
- Signed written informed consent to participate in the study.
Who cannot join
- Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
- Subjects who receive oral anti-coagulation treatment (warfarin)
- Subjects who receive Acetyl Salicylic Acid [(ASA), aspirin] 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 EPODURE procedure
- Patients currently receiving injections of long-acting ESA's (Aranesp, Mircera, etc.)
- Congestive heart failure (New York Heart Association functional class III or IV).
- Grand mal seizures within 2 years of the screening visit.
Show all 14Show fewer
- 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.
- 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).
About this study
Official title: Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in End Stage Renal Disease (ESRD) Dialysis Patients Using EPODURE Biopump
In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo. The implant secretes the patients own epo minimizing the need for injections for a period of up to 6 months.
Read the detailed description
This will be a Phase I-II, open-label, single-center, uncontrolled, tailored dose study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl.
- Conditions
- Anemia, End Stage Renal Disease
- Being tested
- implantation of autologous skin graft after ex-vivo treatment, Subcutan implantation of autologus skin graft after ex-vivo treatment
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of autologous skin graft after ex-vivo treatmentProcedure or surgery
Subcutan implantation of autologous skin graft after ex-vivo treatment
Subcutan implantation of autologus skin graft after ex-vivo treatmentBiological
Subcutan implantation of autologus skin graft after ex-vivo treatment
| Study group | Role | What they receive |
|---|---|---|
| EPODURE Low dose | Experimental | EPODURE pump secreting hEPO 18-25 IU/kg/day Receives: Procedure: implantation of autologous skin graft after ex-vivo treatment; Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hg maintenance with in the range of 10-12 gr/dl for the duration of 6 month
A Phase I-II, open-label. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl.
Measured: 6 months
Secondary outcomes (1)
REDUCING THE AMOUNT OF EXOGENOUS EPO ADMINISTRATION
The biopumps are expected to secret sufficient Epo to support the Hb lebel in the desired range of 10-12 gr/dl
Measured: During the first 6 months of evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionApr 2014
Why it stopped: New protocol to start with improved product
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medgenics Medical Israel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Schwartz, Professor, Principal investigator, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555515
- Sponsor's protocol ID
- MG-001-03
- Status last verified
- Oct 2015
- First submitted
- 13 Mar 2012
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Early phase study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. 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 End Stage Renal Disease (ESRD) Dialysis Patients Using EPODURE Biopump
- ClinicalTrials.gov ID
- NCT01555515
- Acronym / sponsor ID
- MG-001-03
- Conditions
- Anemia, End Stage Renal Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New protocol to start with improved product
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medgenics Medical Israel Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Mar 2012 (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.
In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo. The implant secretes the patients own epo minimizing the need for injections for a period of up to 6 months.
Detailed description
This will be a Phase I-II, open-label, single-center, uncontrolled, tailored dose study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPODURE Low dose | Experimental | Procedure: implantation of autologous skin graft after ex-vivo treatment, Biological: Subcutan implantation of autologus skin graft after ex-vivo treatmentEPODURE pump secreting hEPO 18-25 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 (8 listed)
- Adult male or female subjects between 18 to 75 years of age at the time of screening visit.
- Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on dialysis treatment for at least 3 months. Hb < 12g/dL on 2 consecutive measures
- Kt/V >1
- INR not higher than 1.2
- Subjects who are clinically stable.
Key exclusion criteria (14 listed)
- Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
- Subjects who receive oral anti-coagulation treatment (warfarin)
- Subjects who receive Acetyl Salicylic Acid [(ASA), aspirin] 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 EPODURE procedure
- Patients currently receiving injections of long-acting ESA's (Aranesp, Mircera, etc.)
- Congestive heart failure (New York Heart Association functional class III or IV).
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 |
|---|---|---|
| implantation of autologous skin graft after ex-vivo treatmentSubcutan implantation of autologous skin graft after ex-vivo treatment | Procedure or surgery | EPODURE Low dose |
| Subcutan implantation of autologus skin graft after ex-vivo treatmentSubcutan implantation of autologus skin graft after ex-vivo treatment | Biological | EPODURE Low dose |
Primary outcome
Hg maintenance with in the range of 10-12 gr/dl for the duration of 6 month
Time frame: 6 months
A Phase I-II, open-label. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center. Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl.
1 secondary outcome
REDUCING THE AMOUNT OF EXOGENOUS EPO ADMINISTRATION
Time frame: During the first 6 months of evaluation
Results and safety
The study was stopped early (reason given: New protocol to start with improved product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No. Early phase study.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Doron Schwartz, Professor principal investigator
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing implantation of autologous skin graft after ex-vivo treatment and Subcutan implantation of autologus skin graft after ex-vivo treatment in people with Anemia and End Stage Renal Disease, run by Medgenics Medical Israel Ltd..
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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: New protocol to start with improved product). Results are not available in the source record.
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?
Hg maintenance with in the range of 10-12 gr/dl for the duration of 6 month (time frame: 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 13 Sep 2016.