Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patie... | Not Recruiting
Roxadustat in the Treatment of Anem... | Not Recruiting
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
Dolomites

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Medical Conditions
  • Anemia in Chronic Kidney Disease in Non-dialysis Patients
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02021318
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This study is conducted to explore a new therapy for anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of the study is to see if Roxadustat is effective and safe to treat anemia in patients with chronic kidney disease. Roxadustat will in this study be compared to darbepoetin alfa, a commercially available medicine for treatment of anemia (tradename Aranesp).
Research Details
  • This study will consist of three study periods as follows:

    - Screening Period: from 2 up to 6 weeks

    - Treatment Period: 104 weeks

    - Follow-up Period: 4 weeks
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Roxadustat, Drug : darbepoetin alfa

Study Arm Groups : Roxadustat, darbepoetin alfa

Intervention Type
See Interventions above
Primary Outcome Measures
    Hemoglobin (Hb) response to treatment with Roxadustat without the use of rescue therapy; Up to week 24
Secondary Outcome Measures
    Hb change from baseline (BL) to the average Hb, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period; Baseline and weeks 28 to 36; Change from BL in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol; Baseline and weeks 12 to 28; Mean monthly intravenous(ly) (IV) iron (mg) use per subject; Up to week 36; Change from BL in Short Form 36 (SF-36) Physical Functioning (PF) sub-score to the average PF sub-score; Baseline and weeks 12 to 28; Change from BL in SF-36 Vitality (VT) sub-score to the average VT sub-score; Baseline and weeks 12 to 28; Change from BL in mean arterial pressure (MAP) to the average MAP value; Baseline and weeks 20 to 28; Occurrence of hypertension; Up to week 36; Time to occurrence of hypertension; Up to week 36; Hb change from BL to the average Hb value regardless of rescue therapy; Baseline and weeks 28 to 52; Time (weeks) to achieve the first Hb response as defined by primary endpoint; Up to week 24; Hb response; Up to week 24; Hb averaged over weeks 28 to 36, 44 to 52, 72 to 80, 96 to 104, without use of rescue therapy within 6 weeks prior to and during this evaluation period; Up to week 104; Hb value to each post-dosing time point; Up to End of Study (EOS) (Up to week 108); Hb change from BL to each post-dosing time point; Baseline up to End of Study (EOS) (Up to week 108); Hb change from BL to the average Hb value regardless of the use of rescue therapy; Baseline, weeks 28 to 36, weeks 44 to 52, weeks 72 to 80, weeks 96 to 104; Proportion of Hb values within 10.0 to 12.0 g/dL in weeks 28 to 36, 44 to 52, 72 to 80, 96 to 104, without use of rescue therapy within 6 weeks prior to and during the 8-week evaluation period; Up to week 104; Occurrence (number) of hospitalization(s); Up to End of Treatment (EOT) (Up to week 104); Number of days of hospitalization; Up to End of Treatment (EOT) (Up to week 104); Number of subjects having received rescue therapy (composite of red blood cell (RBC) transfusions (all subjects) and darbepoetin alfa use (roxadustat treated subjects only); Up to End of Treatment (EOT) (Up to week 104); Number of subjects having received RBC transfusions; Up to End of Treatment (EOT) (Up to week 104); Number of RBC packs per subject; Up to End of Treatment (EOT) (Up to week 104); Volume of RBC transfused per subject; Up to End of Treatment (EOT) (Up to week 104); Change from BL to each scheduled measurement in total cholesterol; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in low density lipoprotein (LDL)/high-density lipoprotein (HDL) ratio; Baseline up to End of Study (EOS) (up to week 108); Change from BL to each scheduled measurement in non-HDL cholesterol; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in Apolipoproteins (Apo) A1; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in Apolipoproteins B (ApoB); Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in ApoB/ApoA1 ratio; Baseline up to End of Study (EOS) (Up to week 108); Occurrence of mean LDL cholesterol < 100 mg/dL (mean LDL calculated over weeks 12 to 28, and weeks 36 to 52 of treatment); Up to week 52; Occurrence of achieved anti-hypertensive treatment goal (SBP < 130 mmHg and DBP< 80 mmHg) based on the mean SBP and mean DBP calculated over weeks 12 to 28 and 36 to 52 of treatment with study drug; Up to week 52; Change from BL to the average value in Physical Component Score (PCS) of SF-36; Baseline, weeks 12 to 28 and weeks 36 to 52; Change from BL to the average value in Anemia Subscale ("Additional Concerns") of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score; Baseline, weeks 12 to 28 and weeks 36 to 52; Change from BL to the average value in Total FACT-An Score; Baseline, weeks 12 to 28 and weeks 36 to 52; Change from BL to the average value in Health Related Quality of Life Questionnaire consisting of Five Levels (EQ-5D 5) visual analogue scale (VAS) Score; Baseline, weeks 12 to 28 and weeks 36 to 52; Change from BL to the average value in Work Productivity and Activity Impairment-Anemic Symptoms (WPAI:ANS) score; Baseline, weeks 12 to 28 and weeks 36 to 52; Patients' Global Impression of Change (PGIC); Up to End of Treatment (EOT) (up to Week 104); Change from BL to each scheduled measurement serum ferritin; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in Transferrin Saturation (TSAT); Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in HbA1c; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in fasting blood glucose; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in Estimated Glomerular Filtration Rate (eGFR), including eGFR slope over time; Baseline up to End of Study (EOS) (Up to week 108); Change from BL to each scheduled measurement in Urine albumin/creatinine ratio (UACR); Baseline up to End of Study (EOS) (Up to week 108); Time to first of occurrence of serum creatinine having doubled during study in comparison with baseline; Up to End of Study (EOS) (Up to week 108); Occurrence of ESRD; Up to End of Study (EOS) (Up to week 108); Safety assessed by nature, frequency, and severity of Treatment Emergent AEs (TEAEs); Up to End of Study (EOS) (Up to week 108); Number of participants with laboratory value abnormalities and/or adverse events related to treatment; Up to End of Study (EOS) (Up to week 108); Number of participants with vital signs abnormalities and/or adverse events related to treatment; Up to End of Study (EOS) (Up to week 108); Safety assessed by 12- lead electrocardiogram (ECG); Up to End of Study (EOS) (Up to week 108); Occurrence of prespecified adjudicated cardiovascular events; Up to End of Study (EOS) (Up to week 108); Occurrence of prespecified adjudicated cerebrovascular events; Up to End of Study (EOS) (Up to week 108)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Subject has a diagnosis of CKD, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not on dialysis; with an Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m^2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.

    - The mean of the subject's two most recent (prior to randomization) Hb values during the screening period, obtained at least 4 days apart, must be less than or equal to 10.5 g/dL, with a difference of less than or equal to 1.0 g/dL. The last Hb value must be within 10 days prior to randomization.

    - Subject is deemed suitable for treatment with Erythropoiesis Stimulating Agent (ESA) using the criteria specified in the Kidney Disease Improving Global Outcomes (KDIGO) 2012 recommendation considering the rate of fall of Hb concentration, prior response to iron therapy, the risk of needing a transfusion, the risks related to ESA therapy and the presence of symptoms attributable to anemia.

    - Subject has a serum folate level greater than or equal to lower limit of normal (LLN) at screening.

    - Subject has a serum vitamin B12 level greater than or equal to LLN at screening.

    - Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than or equal to 3 x upper limit of normal (ULN), and total bilirubin (TBL) is less than or equal to 1.5 x ULN.

    - Subject's body weight is 45.0 kg to a maximum of 160.0 kg.

    - Male subject must not donate sperm starting from screening, throughout the study period and up to 12 weeks after final study drug administration.

    Exclusion Criteria:

    - Subject has received any Erythropoiesis Stimulating Agent (ESA) treatment within 12 weeks prior to randomization.

    - Subject has received any dose of IV iron within 6 weeks prior to randomization.

    - Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization.

    - Subject has a known history of myelodysplastic syndrome or multiple myeloma.

    - Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD).

    - Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.

    - Subject has a known chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.

    - Subject is anticipated to undergo elective surgery that is expected to lead to significant blood loss during the study period or anticipated elective coronary revascularization.

    - Subject has active or chronic gastrointestinal bleeding.

    - Subject has received any prior treatment with roxadustat or a Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

    - Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.

    - Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver).

    - Subject has known New York Heart Association Class III or IV congestive heart failure.

    - Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.

    - Subject has one or more contraindications for treatment with darbepoetin alfa:

    - Uncontrolled hypertension, or two or more blood pressure values of SBP greater than or equal to 160 mmHg or DBP greater than or equal to 95 mmHg (within 2 weeks prior to randomization).

    - Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, or any of the excipients.

    - Subject has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma as shown on renal ultrasound within 12 weeks prior to randomization.

    - Subject has a history of malignancy, except for the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.

    - Subject is positive for any of the following:

    - human immunodeficiency virus (HIV).

    - hepatitis B surface antigen (HBsAg).

    - or anti-hepatitis C virus antibody (anti-HCV Ab).

    - Subject has an active clinically significant infection that is manifested by White Blood Count (WBC) > Upper Limit of Normal (ULN), and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization.

    - Subject has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration or retinal vein occlusion.

    - Subject has had any prior organ transplant (that has not been explanted), subject is scheduled for organ transplantation, or subject is likely to initiate renal replacement therapy including dialysis within the first year of the study.

    - Subject will be excluded from participation if any of the following apply:

    - subject has received investigational therapy within 30 days or 5 half lives or limit set by national law, whichever is longer, prior to initiation of screening, or

    - any condition which makes the subject unsuitable for study participation.

    - Subject has an anticipated use of dapsone in any dose amount or chronic use of acetaminophen/paracetamol >2.0 g/day during the treatment or follow-up period of the study.

    - Subject has a history of alcohol or drug abuse within 2 years prior to randomization
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Dorchester
DT1 2JY
London
SW17 0QT
London
SE5 9RS
Bordesley Green
B9 5SS
Cwmrhydyceirw
SA6 6NL
Stoke-on-Trent
ST4 6QG
Orpington
BR6 8ND
London
E1 1BB
Nottingham
Nottinghamshire
NG5 1PB
Fulwood
Lancashire
PR2 9HT
Leicester
LE5 4PW
Dartford
DA2 8DA
King's Lynn
PE30 4ET
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belarus, Bulgaria, Croatia, Czechia, Finland, France, Georgia, Germany, Hungary, Ireland, Israel, Latvia, Macedonia, The Former Yugoslav Republic of, Montenegro, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Ukraine, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
EudraCT Number
Not available for this trial
Funder(s)
  • FibroGen
Other Study ID Numbers
1517-CL-0610
Sponsor(s)
Astellas Pharma Europe B.V.
Key Dates

Recruitment Start Date

Mar 2014

Recruitment End Date

Mar 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

20 Dec 2013

Date updated in source

30 Oct 2018