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

NCT01555515 | Terminated Phase 1

• 1 other identifier: MG-001-03
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief 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. The implant secretes the patients own epo minimizing the need for injections for a period of up to 6 months.

Conditions

Anemia; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• REDUCING THE AMOUNT OF EXOGENOUS EPO ADMINISTRATION

  During the first 6 months of evaluation

Study Arms (1)

EPODURE Low dose

EXPERIMENTAL

EPODURE pump secreting hEPO 18-25 IU/kg/day

Procedure: implantation of autologous skin graft after ex-vivo treatment; Biological: Subcutan implantation of autologus skin graft after ex-vivo treatment

Interventions

implantation of autologous skin graft after ex-vivo treatment PROCEDURE

Subcutan implantation of autologous skin graft after ex-vivo treatment

EPODURE Low dose

Subcutan implantation of autologus skin graft after ex-vivo treatment BIOLOGICAL

Subcutan implantation of autologus skin graft after ex-vivo treatment

EPODURE Low dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Medgenics Medical Israel Ltd.: lead

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Doron Schwartz, Professor

  Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: September 13, 2016

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share