Chronic Kidney DiseasePhase 1/2NCT02117427

TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)

A Phase 1/2 study testing MDGN201 TARGTEPO in people with Chronic Kidney Disease and End Stage Renal Disease, run by Aevi Genomic Medicine, LLC, a Cerecor company at 5 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Kidney Disease, End Stage Renal Disease
What is being tested?: MDGN201 TARGTEPO
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 5 sitesIsrael
Study dates: 27 May 2014to 20 Mar 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For ESRD patients: Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on hemodialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL.
Kt/V >1
INR not higher than 1.2
Serum albumin >3.5
Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >100 ng/ml).

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 (e.g. warfarin)
Subjects who receive Acetyl Salicylic Acid (ASA) 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 Erythropoiesis Stimulating Agents (ESA) (e.g. Aranesp, Mircera), a patient on long acting ESA can be switched to a short acting preparation (e.g Eprex) and enroll in the study after meeting the inclusion criteria and not meeting any other exclusion criteria.
Congestive heart failure (New York Heart Association functional class III or IV).
Grand mal seizures within 2 years of the screening visit.

Show all 27Show 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, thalassemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
Current systemic infection, active inflammatory disease, or malignancy under active 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 heart 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 or five half-lives of the investigational drug whichever is longer, since ending other investigational device or drug trial(s) prior to Screening phase.
Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
Female subjects of child-bearing potential and males that do not agree to use acceptable methods of contraception during the study.
Pregnant and lactating female subjects.
Chronic alcoholic or drug abuse subjects.
Steroid or other immunosuppressive treatment (other than topical or inhaled steroids).
Subjects unwilling or unable to comply with the study procedures.
EPO Naïve subjects.
Known sensitivity to Gentamycin and Amphotericin
History of chronic or active Hepatitis B and/or C infection or positive serology at screening and known positive HIV or positive serology at screening.
Subject had blood transfusion within 84 days prior to Screening visit.
Subject has a date for renal transplantation.
Subject has a temporary or permanent hemodialysis catheter, unless: Subject has a permanent hemodialysis catheter over 6 months without signs/events of line sepsis.
Refer to the USPI - Depo-Medrol - Methylprednisolone Acetate - Injectable (Appendix A) for any concomitant drug taken by the patient which its interaction with Depo-Medrol will warrant exclusion from this protocol.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Israel5 sites

Barzili Medical Center
Ashkelon
Meir Medical Center
Kfar Saba
Medical Center of the Galilee
Nahariya
Tel Aviv Sourasky Medical Center
Tel Aviv
Assaf Harofeh Medical Center
Zrifin

Other trials in Israel

About this study

Official title: Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) Dialysis Patients Using MDGN201 TARGTEPO

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.

Read the detailed description

This is a Phase I-II, open-label study. Each patient will receive targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to 3 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day), Group C (55-65 IU/Kg/day). The objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining Hb levels within the target range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline

Conditions: Chronic Kidney Disease, End Stage Renal Disease
Being tested: MDGN201 TARGTEPO
Medical subject headings: Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MDGN201 TARGTEPOBiological
Erythropoietin secreted by TARGTEPO transduced with MDGN201

Study groups in NCT02117427
Study group	Role	What they receive
Group A	Experimental	MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day) Receives: Biological: MDGN201 TARGTEPO
Group B	Experimental	MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day) Receives: Biological: MDGN201 TARGTEPO
Group C	Experimental	MDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day) Receives: Biological: MDGN201 TARGTEPO

What is being measured

The primary outcome is the main question the study is designed to answer.

Total EPO Secretion
Measured: up to 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL
Measured: 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL
Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 201420 Mar 2017

First posted21 Apr 2014 (estimated)
Study start27 May 2014
Primary completion30 Jun 2016
Study completion20 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02117427
Sponsor's protocol ID: MG-EP-RF-02
Status last verified: Feb 2018
First submitted: 16 Apr 2014
Last updated: 30 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2018. 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 Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) Dialysis Patients Using MDGN201 TARGTEPO
ClinicalTrials.gov ID: NCT02117427
Acronym / sponsor ID: MG-EP-RF-02
Conditions: Chronic Kidney Disease, End Stage Renal Disease
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Aevi Genomic Medicine, LLC, a Cerecor companyIndustry (pharma, biotech, devices)
Collaborators: Medgenics Medical Israel Ltd.
Study start: 27 May 2014 (actual)
Primary completion: 30 Jun 2016 (actual)
Study completion: 20 Mar 2017 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 30 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: MDGN201 TARGTEPOMDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)
Group B	Experimental	Biological: MDGN201 TARGTEPOMDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
Group C	Experimental	Biological: MDGN201 TARGTEPOMDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

For ESRD patients: Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on hemodialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL.
Kt/V >1
INR not higher than 1.2
Serum albumin >3.5
Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >100 ng/ml).

Key exclusion criteria (27 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 (e.g. warfarin)
Subjects who receive Acetyl Salicylic Acid (ASA) 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 Erythropoiesis Stimulating Agents (ESA) (e.g. Aranesp, Mircera), a patient on long acting ESA can be switched to a short acting preparation (e.g Eprex) and enroll in the study after meeting the inclusion criteria and not meeting any other exclusion criteria.
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
MDGN201 TARGTEPOErythropoietin secreted by TARGTEPO transduced with MDGN201	Biological	Group A, Group B, Group C

Primary outcome

Total EPO Secretion
Time frame: up to 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL
Time frame: 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL
Time frame: 52 weeks
Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d.

Results and safety

Results posted to the registry on 30 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: 18-25 IU/Kg/Day	6	1
Group B: 35-45 IU/Kg/Day	5	0
Group C: 55-65 IU/Kg/Day	0	0

Primary outcome: Total EPO Secretion

Time frame: up to 52 weeks. Mean (Full Range). Unit: U/Kg/d

Measure	All Subjects Enrolled n = 10
Value	24.1 (16.5 to 50.8)

Population analysed: Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d. One subject enrolled was discontinued prior to study procedures and became no longer eligible.

Primary outcome: Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL

Time frame: 52 weeks. Mean (Full Range). Unit: percent

Measure	All Subjects Enrolled n = 10
Value	49.2 (1.7 to 88.1)

Primary outcome: Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL

Time frame: 52 weeks. Mean (Full Range). Unit: percent

Measure	All Subjects Enrolled n = 10
Value	75.3 (25.0 to 88.1)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
Group B	4 of 4 (100%)	4 of 4 (100%)	1 of 4
Group C	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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.

Shany Blum, MD PhD study director

Aevi Genomic Medicine, LLC, a Cerecor company

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MDGN201 TARGTEPO in people with Chronic Kidney Disease and End Stage Renal Disease, run by Aevi Genomic Medicine, LLC, a Cerecor company at 5 sites in Israel.

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 5 inclusion and 27 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: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 30 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total EPO Secretion (time frame: up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117427.

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 30 Oct 2018.