Victoria Socha

DocwireNews

During a poster session at Kidney 
Week 2019, researchers, led by Ciro Esposito, MD, PhD, MFAS, presented 
results of two phase 3 European studies of roxadustat, an oral 
hypoxia-inducible factor prolyl hydroxylase inhibitor in late-stage development 
for the treatment of anemia in patients with chronic kidney disease (CKD). The 
poster was titled Two Phase 3, Multicenter, Randomized Studies of 
Intermittent Oral Roxadustat in Anemic CKD Patients on (PYRENEES) and Not on 
(ALPS) Dialysis.


The open-label PYRENEES study 
enrolled 836 stable hemodialysis or peritoneal dialysis-dependent CKD patients 
with anemia with hemoglobin 9.5 to 12 g/dL treated with erythropoiesis-stimulating 
agents (ESAs). Patients were randomized 1:1 to oral roxadustat or ESAs for 52 
to 104 weeks. In the double-blind ALPS study, non–dialysis-dependent CKD 
patients with anemia with hemoglobin ≤10 g/L not treated with ESAs were 
randomized 2:1 to oral roxadustat or placebo for 52 to 104 weeks.


Primary end points were change from 
baseline of average levels of hemoglobin at weeks 28 to 52. Secondary end 
points included change of average low-density lipoprotein cholesterol (LDL) at 
weeks 12 to 28 from baseline, and time to use of rescue therapy (PYRENEES: 
transfusion, ESA, intravenous [IV] iron and ALPS: mean monthly IV iron use 
through week 36). The researchers also examined the occurrence of adverse 
events.


The ALPS study included 594 patients: 
391 were randomized to roxadustat and 203 were randomized to placebo. At weeks 
28 to 52, the mean change of average hemoglobin from baseline was 1.988 for 
patients in the roxadustat group and 0.406 for those in the placebo group (P&lt;.001). 
The least squares mean difference in LDL was  -0.701 (95% confidence interval [CI], -0.83 to -0.57; P&lt;.001) mmol/L in the 
roxadustat group versus placebo. Roxadustat was superior to placebo in time to 
use of rescue therapy (hazard ratio, 0.238; 95% CI, 0.17-0.33); P&lt;.001).


In the dialysis-dependent patient 
study (PYRENEES), the mean change of average hemoglobin levels at weeks 28 to 
52 from baseline was 0.396 for the roxadustat group and 0.183 for the ESA group 
(P&lt;.001). The least squares mean difference in LDL in the roxadustat 
group was -0.377 (95% CI, -0.451 to -0.304; P&lt;.001) mmol/L 
versus the ESA group. Roxadustat was superior to ESA in mean monthly IV iron 
use (least square mean difference, ­31.9 (95% CI, -41.4 to -22.4; P&lt;.001).


In the ALPS study, adverse events 
included end-stage renal disease, hypertension, peripheral edema, and decreased 
glomerular filtration rate in both groups. In the PYRENEES study, common adverse 
events were hypertension, arteriovenous fistula thrombosis, headache, and 
diarrhea.


In conclusion, the researchers said, 
“Roxadustat was effective in achieving and maintaining hemoglobin levels 
compared with placebo and ESA in non–dialysis-dependent and dialysis-dependent 
CKD patients.”


Source: Esposito C, Csiky B, 
Tataradze A, Reusch M, Han C, Sulowicz W. Two phase 3, multicenter, randomized 
studies of intermittent oral roxadustat in anemic CKD patients on (PYRENEES) 
and Not on (ALPS) dialysis. Abstract of a poster presented at the American 
Society of Nephrology Kidney Week 2019 (Abstract SA-PO225), November 9, 2019, 
Washington, DC.

During a poster session at Kidney 
Week 2019, researchers, led by Ciro Esposito, MD, PhD, MFAS, presented 
results of two phase 3 European studies of roxadustat, an oral 
hypoxia-inducible factor prolyl hydroxylase inhibitor in late-stage development 
for the treatment of anemia in patients with chronic kidney disease (CKD). The 
poster was titled Two Phase 3, Multicenter, Randomized Studies of 
Intermittent Oral Roxadustat in Anemic CKD Patients on (PYRENEES) and Not on 
(ALPS) Dialysis.The open-label PYRENEES study 
enrolled 836 stable hemodialysis or peritoneal dialysis-dependent CKD patients 
with anemia with hemoglobin 9.5 to 12 g/dL treated with erythropoiesis-stimulating 
agents (ESAs). Patients were randomized 1:1 to oral roxadustat or ESAs for 52 
to 104 weeks. In the double-blind ALPS study, non–dialysis-dependent CKD 
patients with anemia with hemoglobin ≤10 g/L not treated with ESAs were 
randomized 2:1 to oral roxadustat or placebo for 52 to 104 weeks.Primary end points were change from 
baseline of average levels of hemoglobin at weeks 28 to 52. Secondary end 
points included change of average low-density lipoprotein cholesterol (LDL) at 
weeks 12 to 28 from baseline, and time to use of rescue therapy (PYRENEES: 
transfusion, ESA, intravenous [IV] iron and ALPS: mean monthly IV iron use 
through week 36). The researchers also examined the occurrence of adverse 
events.The ALPS study included 594 patients: 
391 were randomized to roxadustat and 203 were randomized to placebo. At weeks 
28 to 52, the mean change of average hemoglobin from baseline was 1.988 for 
patients in the roxadustat group and 0.406 for those in the placebo group (P&lt;.001). 
The least squares mean difference in LDL was  -0.701 (95% confidence interval [CI], -0.83 to -0.57; P&lt;.001) mmol/L in the 
roxadustat group versus placebo. Roxadustat was superior to placebo in time to 
use of rescue therapy (hazard ratio, 0.238; 95% CI, 0.17-0.33); P&lt;.001).In the dialysis-dependent patient 
study (PYRENEES), the mean change of average hemoglobin levels at weeks 28 to 
52 from baseline was 0.396 for the roxadustat group and 0.183 for the ESA group 
(P&lt;.001). The least squares mean difference in LDL in the roxadustat 
group was -0.377 (95% CI, -0.451 to -0.304; P&lt;.001) mmol/L 
versus the ESA group. Roxadustat was superior to ESA in mean monthly IV iron 
use (least square mean difference, ­31.9 (95% CI, -41.4 to -22.4; P&lt;.001).In the ALPS study, adverse events 
included end-stage renal disease, hypertension, peripheral edema, and decreased 
glomerular filtration rate in both groups. In the PYRENEES study, common adverse 
events were hypertension, arteriovenous fistula thrombosis, headache, and 
diarrhea.In conclusion, the researchers said, 
“Roxadustat was effective in achieving and maintaining hemoglobin levels 
compared with placebo and ESA in non–dialysis-dependent and dialysis-dependent 
CKD patients.”Source: Esposito C, Csiky B, 
Tataradze A, Reusch M, Han C, Sulowicz W. Two phase 3, multicenter, randomized 
studies of intermittent oral roxadustat in anemic CKD patients on (PYRENEES) 
and Not on (ALPS) dialysis. Abstract of a poster presented at the American 
Society of Nephrology Kidney Week 2019 (Abstract SA-PO225), November 9, 2019, 
Washington, DC.

Nsisong Asanga, PhD

New Study Shows Extended Mesenteric Resection Has No Benefits in Crohn’s Disease

Gastroenterology

Leslie Feldman

New Discovery Reveals How the Body May Help Defeat Hepatitis B

Hepatitis

How Hepatitis B Makes the Liver More Vulnerable to Cancer — And What We Can Do About It

Latest News

Phase 3 Studies of Roxadustat: PYRENEES and ALPS

ASN Kidney Week 2019

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HER2 Breast Cancer

HR Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Diabetes

Obesity

Metabolic Care Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Urology

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe