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AnemiaPhase 2NCT02044653

Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)

A Phase 2 study testing GX-E2, NESP and MIRCERA in people with Anemia and Chronic Kidney Disease, run by Genexine, Inc. at 5 sites in South Korea.

Completed

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

Official record
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Trial summary

The primary objective of study is Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2 Part B : To evaluate the proof of concept (POC) of GX-E2 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anemia, Chronic Kidney Disease
What is being tested?
GX-E2, NESP and MIRCERA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
5 sitesSouth Korea
Study dates
15 Apr 2014to 20 Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written informed consent
  • ≥18 yr of age
  • Chronic Kidney diseases with hemodialysis, peritoneal dialysis with Kt/V ≥ 1.2 (hemodialysis) or Kt/V ≥ 1.7 (peritoneal dialysis) within a year
  • Adequate transferrin saturation (≥20%), serum ferritin (≥100ug/L)
  • Should have received Vitamine B12 ≥ 3 months before the first dose of study agent
  • Should have received Folate ≥3 months before the first dose of study agent
  • No erythropoietin (EPO) therapy within 2 months before the planned first dose of GX-E2 and Hb<10g/dL or No EPO therapy within a month (peritoneal dialysis) or 2 weeks (hemodialysis) before the planned first dose of GX-E2 and Hb<10g/dL.

Who cannot join

  • Refractory to erythropoiesis stimulating agent (ESA) treatment
  • History of blood transfusion within 3 months
  • Donation or loss of blood for more than 400 milliliters (mL) within 8 weeks
  • History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar ESA drugs
  • Acute or chronic organ seizure disorder (including asthma and chronic obstructive pulmonary disease) which may be clinically deteriorated by the drug administration
  • Active infection or history of infection that required intravenous injection of antibiotics in the last two months
Show all 30Show fewer
  • Grand Mal epilepsy
  • Major surgery within 3 months other than access surgery
  • Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
  • Ischemic stroke within 3 years
  • Chest x-ray findings determined that they cannot participate in the study for clinically abnormal findings by the baseline chest x-ray findings or previously taken chest x-ray findings
  • Uncontrolled hypertension
  • Congestive heart failure more severe than NYHA functional class III; unstable Coronary artery disease (CAD); myocardial infraction within 3 months
  • Uncontrolled arrhythmia
  • High risk of thrombosis and embolism
  • Systemic blood diseases (e.g. Pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia)
  • Absolute neutrophil count below 1,500 per microliter (uL) within screening periods
  • Platelet count less than 5e10 per liter (L) within screening periods
  • Hyperparathyrodism / hypothyrodism
  • Splenomegaly caused by anemia or severe splenomegaly (>20cm)
  • Blood aspartate aminotransferase/alanine aminotransferase (ALT/AST) concentration exceeds three times Upper Normal Limit of Normal (UNL)
  • Blood total bilirubin concentration exceeds 1.5 times Upper Normal Limit of Normal (UNL)
  • Blood albumin concentration below 3g per deciliter (dl)
  • History of drug or alcohol abuse in the 6 months prior to the screening
  • History of psychotropic or narcotic analgesic drugs dependence within 6 months prior to the screening
  • Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
  • Lack of understanding of the study and cooperation (one with no intention to give efforts to perform each evaluation visit and extend previously planned elective surgery)
  • Female subjects with childbearing potential who are pregnant, breastfeeding or intends to become pregnant
  • Participation in any drug study within 30 days prior to dosing
  • Any other ineligible condition at the direction of the investigator that would be ineligible to participate the study

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Bucheon St. Mary's Hospital

    Bucheon-si

  • Bundang Seoul National University College of Medicine

    Gumi

  • The Catholic University of Korea Incheon St.Mary's Hospital

    Incheon

  • Gangnam severance hospital

    Seoul

  • Seoul St.Mary's Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Phase II Clinical Trial to Explore the Optimal Fixed Starting Dose & Dosing Interval and to Evaluate the Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease and Receiving Hemodialysis (HD) / Peritoneal Dialysis (PD)

The primary objective of study is

  • Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2
  • Part B : To evaluate the proof of concept (POC) of GX-E2
Read the detailed description

The secondary objective of study is to evaluate:

  • change of red blood cell indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
  • change of reticulocyte indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
  • safety of GX-E2 when administering intravenously/subcutaneously
  • incidence of blood transfusion in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
  • Immunogenicity in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
Being tested
GX-E2, NESP, MIRCERA
Keywords
Phase 2
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

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

  • GX-E2Drug

    Also called GC1113

    Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg

  • GX-E2Drug

    Also called GC1113

    Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg

  • GX-E2Drug

    Also called GC1113

    Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg

  • NESPDrug

    Also called Aranesp, Darbepoetin alfa

    Each Group of Hemodialysis (n=30) will be administered NESP 30ug

  • MIRCERADrug

    Also called Methoxy Polyethylene glycol-epoetin beta

    Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg

Study groups in NCT02044653
Study groupRoleWhat they receive
Group A (Part A)ExperimentalGX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 3ug/kg
Receives: Drug: GX-E2
Group B (Part A)ExperimentalGX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg
Receives: Drug: GX-E2
Group C (Part A)ExperimentalGX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg
Receives: Drug: GX-E2
Group D (Part A)ExperimentalGX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 3ug/kg
Receives: Drug: GX-E2
Group E (Part A)ExperimentalGX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 5ug/kg
Receives: Drug: GX-E2
Group F (Part A)ExperimentalGX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 8ug/kg
Receives: Drug: GX-E2
Group G (Part B)ExperimentalGX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg
Receives: Drug: GX-E2
Group H (Part B)ExperimentalGX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg
Receives: Drug: GX-E2
Group I (Part B)Active comparatorMIRCERA : Subcutaneously injection every 2 weeks (Q2W) at dose 0.6ug/kg
Receives: Drug: MIRCERA
Group J (Part B)ExperimentalGX-E2 : Intravenously injection every week (Q1W) at dose 5ug/kg
Receives: Drug: GX-E2
Group K (Part B)ExperimentalGX-E2 : Intravenously injection every week (Q1W) at dose 8ug/kg
Receives: Drug: GX-E2
Group L (Part B)ExperimentalGX-E2 : Intravenously injection every 2 weeks (Q2W) at dose 8ug/kg
Receives: Drug: GX-E2
Group M (Part B)Active comparatorNESP : Intravenously injection every week (Q1W) at dose 30ug
Receives: Drug: NESP

What is being measured

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

  1. average change of Hemoglobin level

    change from baseline in Hemoglobin level

    Measured: 6 weeks (Part A) & 14 weeks (Part B)

Secondary outcomes (5)

  1. change of red blood cell indices

    change from baseline in red blood cell indices

    Measured: 6 weeks (Part A) & 14 weeks (Part B)

  2. change of reticulocyte indices

    change from baseline in reticulocyte indices

    Measured: 6 weeks (Part A) & 14 weeks (Part B)

  3. incidence, degree, outcome of adverse event

    Incidence of adverse events

    Measured: 6 weeks (Part A) & 14 weeks (Part B)

  4. incidence, frequency, amount of blood transfusion

    Incidence of adverse events

    Measured: 6 weeks (Part A) & 14 weeks (Part B)

  5. immunogenicity: ratio of neutralizing antibody & binding antibody in subjects

    comparison from pre-treatment to post-treatment

    Measured: 6 weeks (Part A) & 14 weeks (Part B)

Timeline

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

  1. First posted24 Jan 2014 (estimated)
  2. Study start15 Apr 2014
  3. Primary completion20 Apr 2017
  4. Study completion20 Apr 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044653
Sponsor's protocol ID
GX-E2_P2
Status last verified
Oct 2017
First submitted
9 Jan 2014
Last updated
16 Oct 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GX-E2, NESP and MIRCERA in people with Anemia and Chronic Kidney Disease, run by Genexine, Inc. at 5 sites in South Korea.

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 7 inclusion and 30 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 16 Oct 2017. 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 South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

average change of Hemoglobin level (time frame: 6 weeks (Part A) & 14 weeks (Part B)). 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 NCT02044653.

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 16 Oct 2017.

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