Safety and Efficacy of Sustained Erythropoietin Therapy

NCT00542568 | Completed Phase 1 DMC

• 1 other identifier: MG-001-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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 of up to six (6) months.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Safety Endpoints: adverse events; safety laboratory values; immune response by determination of anti-EPO antibodies; dermal safety outcomes

  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

  6 weeks and 4 months

Study Arms (3)

1

EXPERIMENTAL

Cohort 1 (Low Dose group) 18-25 IU/kg/day

Biological: EPODURE (dermal Biopump for erythropoietin)

2

EXPERIMENTAL

Cohort 2 (Intermediate Dose group): 35-45 IU/kg/day

Biological: EPODURE (dermal Biopump for erythropoietin)

3

EXPERIMENTAL

Cohort 3 (High Dose group): 55-65 IU/kg/day

Biological: EPODURE (dermal Biopump for erythropoietin)

Interventions

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

1; 2; 3

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 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Medgenics Medical Israel Ltd.: lead

Study Sites (2)

Hadassah Medical Organization

Jerusalem, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Anemia

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Prof. Eithan Galun, M.D

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Doron Schwartz, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: August 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

IL (2)