Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant

This study has been terminated.
(New protocol to start with improved product)
Sponsor:
Information provided by (Responsible Party):
Medgenics Medical Israel Ltd.
ClinicalTrials.gov Identifier:
NCT01555515
First received: March 13, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Anemia
End Stage Renal Disease
Procedure: implantation of autologous skin graft after ex-vivo treatment
Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in End Stage Renal Disease (ESRD) Dialysis Patients Using EPODURE Biopump

Resource links provided by NLM:


Further study details as provided by Medgenics Medical Israel Ltd.:

Primary Outcome Measures:
  • Hg maintenance with in the range of 10-12 gr/dl for the duration of 6 month [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • REDUCING THE AMOUNT OF EXOGENOUS EPO ADMINISTRATION [ Time Frame: During the first 6 months of evaluation ] [ Designated as safety issue: No ]
    The biopumps are expected to secret sufficient Epo to support the Hb lebel in the desired range of 10-12 gr/dl


Enrollment: 4
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPODURE Low dose
EPODURE pump secreting hEPO 18-25 IU/kg/day
Procedure: implantation of autologous skin graft after ex-vivo treatment
Subcutan implantation of autologous skin graft after ex-vivo treatment
Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment
Subcutan implantation of autologus skin graft after ex-vivo treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1.

  1. Adult male or female subjects between 18 to 75 years of age at the time of screening visit.
  2. 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
  3. Kt/V >1
  4. INR not higher than 1.2
  5. Subjects who are clinically stable.
  6. Serum albumin > 3.5
  7. Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin > 100 ng/ml).
  8. Signed written informed consent to participate in the study.

Exclusion Criteria:

  1. Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
  2. Subjects who receive oral anti-coagulation treatment (warfarin)
  3. 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
  4. Patients currently receiving injections of long-acting ESA's (Aranesp, Mircera, etc.)
  5. Congestive heart failure (New York Heart Association functional class III or IV).
  6. Grand mal seizures within 2 years of the screening visit.
  7. Clinical evidence of severe hyperparathyroidism as defined by PTH levels of > 10 times the upper normal limits.
  8. Major surgery within 12 weeks of the screening visit.
  9. Systemic hematologic diseases (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
  10. Current systemic infection, active inflammatory disease, or malignancy under treatment.
  11. Subjects known to have tested positive at any time in the past for antibodies to erythropoietic proteins.
  12. Subject has history of malignancy within the past 2 years prior to the screening visit, with the exception of basal cell carcinoma.
  13. 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).
  14. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555515

Sponsors and Collaborators
Medgenics Medical Israel Ltd.
Investigators
Principal Investigator: Doron Schwartz, Professor Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
  More Information

No publications provided

Responsible Party: Medgenics Medical Israel Ltd.
ClinicalTrials.gov Identifier: NCT01555515     History of Changes
Other Study ID Numbers: MG-001-03
Study First Received: March 13, 2012
Last Updated: April 16, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 22, 2014