Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
Information source: Genexine, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia; Chronic Kidney Disease
Intervention: GX-E2 (Drug); GX-E2 (Drug); GX-E2 (Drug); NESP (Aranesp) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Genexine, Inc. Official(s) and/or principal investigator(s): Chul-Woo Yang, MD, Principal Investigator, Affiliation: 222 Banpo-daero,Seocho-gu,Seoul 137-701 Korea Seok Joon Shin, MD, Principal Investigator, Affiliation: 403-720, 56 Dongsuro, Pupyung-Gu, Incheon, Republic of Korea Ki Young Na, MD, Principal Investigator, Affiliation: 82, Gumi-ro 173 Beon-gil, Bundnag-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea Ho cheol Song, MD, Principal Investigator, Affiliation: 327 sosaro, onemi-Gu, bucheon, Republic of Korea
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
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: average change of Hemoglobin level
Secondary outcome: change of red blood cell indiceschange of reticulocyte indices incidence, degree, outcome of adverse event incidence, frequency, amount of blood transfusion immunogenicity: ratio of neutralizing antibody & binding antibody in subjects
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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent
- ≥18 yr of age
- Chronic Kidney diseases with hemodialysis, peritoneal dialysis
- Adequate transferrin saturation (≥20%), serum ferritin (≥100g/dl)
- 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 2month before the planned first dose of GX-E2
and Hb<10g/dL or No EPO therapy within month before the planned first dose of GX-E2
and Hb<10g/dL
Exclusion Criteria:
- Uncontrolled hypertension
- Uncontrolled arrhythmia
- History of acute or chronic bronchospastic disease (including asthma and chronic
obstructive pulmonary disease)
- History of hypersensitivity to the study drug or to similar drug
- aspartate aminotransferase/alanine aminotransferase (ALT/AST) > 3 times Upper Normal
Limit of Normal (UNL)
- Absolute neutrophil count ≤ 1,500 per microliter (uL)
- Donation or loss of ≥400 milliliter (mL) of blood within 8 weeks prior to first dose
- Major surgery within 3 months
- Grand Mal epilepsy
- History of drug or alcohol abuse in the 6 months prior to Screening
- Participation in any clinical investigation in the 4 week period prior to dosing
- Refractory of erythropoiesis stimulating agent (ESA) treatment
- Systemic hematologic diseases (e. g. Pure red cell anemia, sickle cell anemia,
myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia)
Locations and Contacts
Bucheon St. Mary's Hospital, Bucheon, Korea, Republic of; Recruiting Ho cheol Song, MD, Phone: 032-340-7015, Email: drsong@catholic.ac.kr
Bundang Seoul National University College of Medicine, Gumi, Korea, Republic of; Not yet recruiting Ki Young Na, MD, Phone: 82-31-787-7014, Email: kyna@snubh.org
The Catholic University of Korea Incheon St.Mary's Hospital, Incheon, Korea, Republic of; Recruiting Seok-Joon Shin, MD, Phone: 82-32-280-5091, Email: imkidney@catholic.ac.kr
Seoul St.Mary'S Hospital, Seoul, Korea, Republic of; Recruiting Yang Chul-Woo, Director, Phone: 82-2-2258-6851, Email: yangch@catholic.ac.kr Yang Chul-Woo, Director, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: February 2, 2015
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