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Submitted by: Pearly Anne Cheng N/A Last Updated by: Pearly Anne Cheng 2019-08-02 09:43:38


A Phase 3, Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy And Safety Of FG-4592 For The Treatment Of Anemia In Chronic Kidney Disease Patients Not On Dialysis

PHRR141111-000807

Fibrogen CKD

2014-CT0224

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy And Safety Of FG-4592 For The Treatment Of Anemia In Chronic Kidney Disease Patients Not On Dialysis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic subjects with Stage 3, 4 or 5 CKD who are not on dialysis. This study is planned to recruit subjects from approximately 125 study centers in North America, Latin America, Australia and Asia. This study will consist of three study periods as follows:      -Screening Period: Up to 6 weeks    -Treatment Period: 52 weeks    -Post-Treatment Follow-Up Period*: 4 weeks     (*or enroll into an Open Label Extension study) Subjects are randomized to 1 of 6 treatment arms defined by their dose frequency during maintenance, as illustrated in Table 1. The randomization will result in a 2:2:2:1:1:1 ratio of subjects receiving FG-4592 or placebo, respectively. Study drug will be dosed TIW initially for Hb correction until subjects achieve Hb values of >11 g/dL at two consecutive study visits, and a Hb increase from baseline by >1 g/dL. Then, either a dose frequency conversion to QW or BIW or a continuation of TIW will occur according to Table 1, defining entry into the maintenance phase.                    Table 1.     Study Drug Dose Frequencies   Treatment Arms Correction Maintenance n (FG-4592) n (Placebo) 1A TIW QW 100* 0 1P TIW QW 0 50* 2A TIW BIW 100 0 2P TIW BIW 0 50 3A TIW TIW 100 0 3P TIW TIW 0 50  A= Active, P= Placebo *These numbers are based on a sample size of 450; these numbers will increase if overall sample size increases  

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2013-09-04 56 2018-05-04 0000-00-00

Completed

Institution Classification Region LTO #
FibroGen, Inc. Private Business United States of America CDRR-NCR-CRO-11
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR CDRR-NCR-CRO-11
Institution Region
FibroGen, Inc. United States of America
Name E-Mail Institution and Institution Address
Paul Michael Posesano paulmichael.posesao@novotech-cro.com Unit A & D 5th Floor Rockwell Business Tower 1, Rockwell Business Center Ortigas Avenue, Baranggay Ugong Pasig City
Name E-Mail Institution and Institution Address
Paul Michael Posesano paulmichael.posesao@novotech-cro.com Unit A & D 5th Floor Rockwell Business Tower 1, Rockwell Business Center Ortigas Avenue, Baranggay Ugong Pasig City
Name Expertise Affiliation
Arlene Munoz, MD Principal Investigator National Kidney and Transplant Institute
Carina Dalay-Dizon, MD Principal Investigator St. Luke's Medical Center - Quezon City
Elizabeth Paz-Pacheco, MD Principal Investigator The Medical City
Jeanette Ybiernas, MD Principal Investigator Davao Doctors Hospital
Josephine R. Valdez, MD Principal Investigator De La Salle Health Sciences Institute
Ma. Theresa L. Bad-Ang, MD Principal Investigator Southern Philippines Medical Center
Project Location Institutional Ethics Review Board
National Kidney and Transplant Institute National Kidney and Transplant Institute Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
The Medical City The Medical City - Institutional Review Board
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Southern Philippines Medical Center DOH XI Cluster Ethics Review Committee

Anemia in Chronic Kidney Disease Patients not on Dialysis  

 Evaluate the efficacy of FG-4592 in the treatment of anemia in CKD subjects not on dialysis over 24 weeks of treatment. Evaluate the safety of FG-4592 therapy over 52 weeks of treatment.  

 Evaluate the effectiveness of three dose frequencies of FG-4592 for maintenance of Hb:           a. Weekly (QW)            b. Twice weekly (BIW)            c. Three times weekly (TIW) Evaluate effect on serum lipid parameters  Evaluate health related quality of life (HRQoL) benefit of FG-4592 in subjects with CKD anemia Evaluate the effect of FG-4592 on blood pressure (BP) Evaluate time to achieve hemoglobin (Hb) response  Evaluate the need for anemia rescue therapy: red blood cell (RBC) transfusion, erythropoiesis-stimulating agent (ESA), or intravenous (IV) iron

Recruiting

  • Argentina
  • Australia
  • Brazil
  • Chile
  • Colombia
  • Hong Kong
  • Malaysia
  • Mexico
  • New Zealand
  • Peru
  • Philippines
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Clinical Trial

Fibrogen CKD

Unspecified

2014-09-25

0000-00-00

36

11

already met global recruitment target

04 Sep 2013

INCLUSION CRITERIA 1.   Age > 18 years 2.   Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines 3.   Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) 2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation 4.   Mean of the three most recent Hb values during the Screening Period, obtained at least 4 days apart, must be ≤10.0 g/dL, with a difference of ≤1.0 g/dL between the highest and the lowest values. The last screening Hb value must be within 10 days prior to randomization 5.   Ferritin >30 ng/mL 6.   TSAT >5%     7.   Serum folate level ≥lower limit of normal 8.   Serum vitamin B12 level ≥lower limit of normal. 9.   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN), and total bilirubin (Tbili) 10.   Body weight 45 to 160 kg EXCLUSION CRITERIA 1.     Any ESA treatment within 12 weeks prior to randomization 2.     More than one dose of IV iron within 12 weeks prior to randomization 3.     RBC transfusion within 8 weeks prior to randomization 4.     Active, clinically significant infection that could be manifested by white blood cell (WBC) count >ULN, and/or fever, in conjunction with clinical signs or symptoms of infection 5.     History of chronic liver disease 6.     New York Heart Association Class III or IV congestive heart failure 7.     Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization 8.     Two or more BP values of systolic BP≥150 mmHg or diastolic BP≥95 mmHg, within 2 weeks prior to randomization 9.     Diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization 10.   History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps 11.   Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab) 12.   Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission 13.   Known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion 14.   Known history of myelodysplastic syndrome or multiple myeloma 15.   Known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD 16.   Known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition 17.   Any prior organ transplant (that has not been explanted), or a scheduled organ transplantation 18.   Anticipated elective surgery that is expected to lead to significant blood loss, or anticipated elective coronary revascularization 19.   Active or chronic gastrointestinal bleeding 20.   Any prior treatment with FG-4592 or a HIF-PHI 21.   Use of iron-chelating agents within 4 weeks prior to randomization 22.   Use of an investigational drug or treatment, participation in an investigational study, or presence of expected carryover effect of an investigational treatment, within 4 weeks prior to randomization 23.   Anticipated use of dapsone in any dose amount or use of acetaminophen >2.0 g/day during the treatment or follow-up periods of the study 24.   History of alcohol or drug abuse within 2 years prior to randomization 25.   Females of childbearing potential, unless using contraception as detailed in the protocol; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subject agrees to use contraception 26.   Pregnant or breastfeeding females Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation

Interventional

Unspecified

FG-4592 is an investigational, novel small molecule drug for oral administration that has not been marketed in any country. The drug is in Phase 3 clinical development in America, Europe, and Asia. It is being developed for the treatment of anemia associated with chronic kidney disease (CKD), including end-stage renal disease (ESRD).  

Date Amendment Classification Reason
2018-03-09 Amendments related to the protocol Addition or deletion of test or measures

Randomized

Double Blind

Unspecified

Parallel

Not Applicable        

Phase III

Utilization Utilization Info
Publication

Planned

Drug Literature

Planned

Oral Presentation
Posters
Others
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