Anemia of End Stage Renal DiseasePhase 2NCT02378662
TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)
A Phase 2 study testing MDGN201 TARGTEPO in people with Anemia of End Stage Renal Disease, run by Aevi Genomic Medicine, LLC, a Cerecor company at 2 sites in Israel.
Trial summary
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia of End Stage Renal Disease
- What is being tested?
- MDGN201 TARGTEPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2015to Jun 2016
- Phase
- Phase 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
- Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on peritoneal dialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL.
- Kt/V >1.
- INR ≤1.2
- Serum albumin >3.2
- 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 Harvest or Implantation procedure
- 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.
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- Major surgery within 12 weeks of the screening visit.
- Systemic hematologic diseases (e.g., sickle cell anemia, thalassemia (excluding Thalassemia minor), 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.
- 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
2 sites in 1 country.
Israel2 sites
Barzili Medical Center
Ashkelon
Assaf Harofeh Medical Center
Zrifin
About this study
Official title: Safety & Efficacy of Prolonged Physiologic Erythropoietin (EPO) Level Treatment of Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)Using MDGN201 TARGTEPO
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients
Read the detailed description
This is a Phase II, open-label study. Each patient will receive targeted dose of Erythropoietin (EPO) delivered via TARGTEPO.
The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 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
- Anemia of End Stage Renal Disease
- Being tested
- MDGN201 TARGTEPO
- Keywords
- Peritoneal Dialysis, End Stage Renal Disease, Anemia
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDGN201 TARGTEPOBiological
MDGN201 TARGTEPO secreting EPO
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJun 2016
Why it stopped: Sponsor's decision of the Early Termination of the study.
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 Anemia of End Stage Renal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medgenics Medical Israel Ltd.
- Responsible party
- Sponsor
- Investigators
- Shany Blum, MD PhD, Study director, Medgenics Medical Israel Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378662
- Sponsor's protocol ID
- MG-EP-RF-03
- Status last verified
- Dec 2017
- First submitted
- 22 Feb 2015
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Early phase and small feasibility study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Prolonged Physiologic Erythropoietin (EPO) Level Treatment of Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)Using MDGN201 TARGTEPO
- ClinicalTrials.gov ID
- NCT02378662
- Acronym / sponsor ID
- MG-EP-RF-03
- Conditions
- Anemia of End Stage Renal Disease
- Keywords
- Peritoneal Dialysis, End Stage Renal Disease, Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision of the Early Termination of the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Aevi Genomic Medicine, LLC, a Cerecor companyIndustry (pharma, biotech, devices)
- Collaborators
- Medgenics Medical Israel Ltd.
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 19 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 in Peritoneal Dialysis patients
Detailed description
This is a Phase II, open-label study. Each patient will receive targeted dose of Erythropoietin (EPO) delivered via TARGTEPO.
The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on peritoneal dialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL.
- Kt/V >1.
- INR ≤1.2
- Serum albumin >3.2
- Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >100 ng/ml).
Key exclusion criteria (25 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 Harvest or Implantation procedure
- Congestive heart failure (New York Heart Association functional class III or IV).
- Grand mal seizures within 2 years of the screening visit.
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 TARGTEPOMDGN201 TARGTEPO secreting EPO | Biological | Group A, Group B |
Primary outcome
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Early phase and small feasibility study.
Related trials for Anemia of End Stage Renal Disease
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A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Chronic Kidney Disease, Renal Anemia
Not yet recruitingPhase 2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
Anemia
Recruiting
Studies on Adsorption International Learning Initiative Global
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Anemia, Kidney Failure
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
Medgenics Medical Israel Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDGN201 TARGTEPO in people with Anemia of End Stage Renal Disease, run by Aevi Genomic Medicine, LLC, a Cerecor company at 2 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 25 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: stopped early, as of the sponsor's last update on 19 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 2 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 phase mean?
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 19 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?
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2018.