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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 indices

change 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

Page last updated: August 20, 2015

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