Back to results

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

Primary Purpose

Anemia, End Stage Renal Disease

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

implantation of autologous skin graft after ex-vivo treatment

Subcutan implantation of autologus skin graft after ex-vivo treatment

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:1.

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.

Exclusion Criteria:

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EPODURE Low dose

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01555515

First Posted

March 13, 2012

Last Updated

September 12, 2016

Sponsor

Medgenics Medical Israel Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01555515

Brief Title

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

Official Title

Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in End Stage Renal Disease (ESRD) Dialysis Patients Using EPODURE Biopump

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

New protocol to start with improved product

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medgenics Medical Israel Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EPODURE Low dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

implantation of autologous skin graft after ex-vivo treatment

Intervention Description

Subcutan implantation of autologous skin graft after ex-vivo treatment

Intervention Type

Biological

Intervention Name(s)

Subcutan implantation of autologus skin graft after ex-vivo treatment

Intervention Description

Subcutan implantation of autologus skin graft after ex-vivo treatment

Primary Outcome Measure Information:

Title

Hg maintenance with in the range of 10-12 gr/dl for the duration of 6 month

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

REDUCING THE AMOUNT OF EXOGENOUS EPO ADMINISTRATION

Description

The biopumps are expected to secret sufficient Epo to support the Hb lebel in the desired range of 10-12 gr/dl

Time Frame

During the first 6 months of evaluation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:1. 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. Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doron Schwartz, Professor

Organizational Affiliation

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Early phase study.

Learn more about this trial

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

We'll reach out to this number within 24 hrs