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

Anemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044653
• Other study ID #: GX-E2_P2
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2014
• Last updated: October 13, 2017
• Start date: April 15, 2014
• Est. completion date: April 20, 2017

Study information

• Verified date: October 2017
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• GX-E2
Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
• GX-E2
Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
• GX-E2
Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
• NESP
Each Group of Hemodialysis (n=30) will be administered NESP 30ug
• MIRCERA
Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St. Mary's Hospital	Bucheon
Korea, Republic of	Bundang Seoul National University College of Medicine	Gumi
Korea, Republic of	The Catholic University of Korea Incheon St.Mary's Hospital	Incheon
Korea, Republic of	Gangnam severance hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average change of Hemoglobin level	change from baseline in Hemoglobin level	6 weeks (Part A) & 14 weeks (Part B)
Secondary	change of red blood cell indices	change from baseline in red blood cell indices	6 weeks (Part A) & 14 weeks (Part B)
Secondary	change of reticulocyte indices	change from baseline in reticulocyte indices	6 weeks (Part A) & 14 weeks (Part B)
Secondary	incidence, degree, outcome of adverse event	Incidence of adverse events	6 weeks (Part A) & 14 weeks (Part B)
Secondary	incidence, frequency, amount of blood transfusion	Incidence of adverse events	6 weeks (Part A) & 14 weeks (Part B)
Secondary	immunogenicity: ratio of neutralizing antibody & binding antibody in subjects	comparison from pre-treatment to post-treatment	6 weeks (Part A) & 14 weeks (Part B)