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. 2023 Jun 1;9(6):e16595. doi: 10.1016/j.heliyon.2023.e16595

Table 8.

Summary of all the 38 completed clinical trials related Roxadustat.

Sr No. NCT Number Interventions Study Title Conditions Sponsor:
1 NCT04076943 Drug: Roxadustat Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia Has Results
  • Chemotherapy Induced Anemia

  • FibroGen•AstraZeneca

  • Astellas Pharma Inc

2 NCT04454879 Drug: Roxadustat Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients
  • Renal Anemia

  • FibroGen•AstraZeneca

  • Astellas Pharma Inc

3 NCT04484857 Drug: Roxadustat Study of Roxadustat Conversion in Participants Receiving
Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
  • Anemia Associated

  • With End Stage

  • Renal Disease

  • FibroGen

  • AstraZeneca

4 NCT04410198 Drug: Roxadustat Study of Roxadustat Conversion in Participants Receiving Stabe Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
  • Anemia Associated

  • With End Stage

Renal Disease (ESRD)
  • FibroGen

  • AstraZeneca

5 NCT04655027 Drug: Roxadustat
Drug: rHuEPO
A Study to Investigate the Effect of Roxadustat
Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease (CKD)
  • Anemia of Chronic

  • Kidney Disease

  • AstraZeneca

  • Parexel

6 NCT02273726 Drug: Epoetin Alfa
Drug: Roxadustat
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants with ESRD on Stable Dialysis •CKD Anemia in Stable Dialysis
  • Patients

  • FibroGen

  • Astellas Pharma

  • Europe B.V.

  • AstraZeneca

7 NCT02965040 Drug: Roxadustat A Phase 1 Study of Roxadustat in Subjects with Different
Degrees of Renal Function
  • Normal Renal

  • Function •Impaired Renal Function

  • Astellas Pharma Europe B.V.

  • FibroGen •Astellas Pharma

  • Inc

8 NCT04059913 Drug: Roxadustat Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants with Chronic Kidney Disease CKD Anemia in Dialysis
  • Participants

  • FibroGen

9 NCT03960489 Drug: Roxadustat A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
  • Healthy Adult

  • Subjects

  • Astellas Pharma Global

  • Development, Inc.

  • FibroGen •Astellas Pharma

  • Inc

10 NCT01887600 Drug: Roxadustat
Drug: Placebo
Roxadustat in the Treatment of Anemia in Chronic Kidney
Disease Patients Not Requiring Dialysis
  • Anemia in Chronic

Kidney Disease in non-dialysisPatients
  • Astellas Pharma Europe B.V.

  • FibroGen

  • Astellas Pharma Inc

11 NCT02052310 Drug: Roxadustat
Drug: Epoetin Alfa
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
  • Anemia in Incident

  • Dialysis Patients

  • FibroGen

  • Astellas Pharma

  • Europe B.V. •AstraZeneca

12 NCT01630889 Drug: Roxadustat Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants with Dialysis and Non-Dialysis Chronic Kidney Disease
  • Chronic Kidney

  • Disease

  • End Stage Renal

  • Disease •Anemia

  • FibroGen •AstraZeneca

  • Astellas Pharma

  • Inc

13 NCT02161224 Drug: FG-4592 A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those with Normal Liver Function
  • PK of FG-4592

  • Hepatic

  • Insufficiency

  • Healthy Subjects

  • Astellas Pharma

  • Europe B.V.

  • FibroGen •Astellas Pharma

  • Inc

14 NCT02021318 Drug: Roxadustat
Drug: Darbepoetin alfa
Roxadustat in the Treatment of Anemia in Chronic Kidney
Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
  • Anemia in Chronic

Kidney Disease in non-dialysis
  • Patients

  • Astellas Pharma

  • Europe B.V. •FibroGen

  • Astellas Pharma Inc

15 NCT02161796 Drug: FG-4592
Drug: Placebo
A Study to Evaluate the Dose proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects
  • PK for FG-4592

  • Healthy Subjects

  • Astellas Pharma

  • Europe B.V. •FibroGen

  • Astellas Pharma Inc

16 NCT02278341 Drug: Roxadustat
Drug: Epoetin alfa
Drug: Darbepoetin alfa
Drug: Iron
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
  • Anemia

  • End Stage Renal

  • Disease (ESRD)

  • Astellas Pharma

  • Europe B.V.

  • FibroGen

  • Astellas Pharma

  • Inc

17 NCT01750190 Drug: Roxadustat
Drug: Placebo
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
  • CKD Anemia

  • FibroGen

  • Astellas Pharma

  • Europe B.V.

  • AstraZeneca

18 NCT01244763 Drug: Roxadustat Study of Roxadustat in Non- Dialysis Chronic Kidney Disease Participants with Anemia
  • Chronic Kidney

  • Disease •Anemia

  • FibroGen

  • Astellas Pharma Inc

19 NCT02252731 Drug: Warfarin
Drug: FG-4592
A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects Pharmacokinetics of FG-4592
  • Healthy Subjects

  • Astellas Pharma

  • Europe B.V. •FibroGen

  • Astellas Pharma Inc

20 NCT02174731 Drug: Roxadustat
Drug: Epoetin alfa
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients with Chronic Kidney Disease, on Dialysis.
  • Anemia

  • AstraZeneca

  • FibroGen

21 NCT01147666 Drug: Roxadustat
Drug: Epoetin Alfa
Other: Placebo
Study of Roxadustat (FG-4592) in Participants with End-Stage Renal Disease Receiving
Maintenance Hemodialysis
  • End Stage Renal

  • Disease

  • Anemia

  • FibroGen

  • AstraZeneca •Astellas Pharma

  • Inc

22 NCT02174627 Drug: Roxadustat
Drug: Placebo
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients with Chronic Kidney
Disease (CKD), Not on Dialysis
  • Anemia

  • AstraZeneca

  • FibroGen

23 NCT00761657 Drug: Roxadustat
Drug: Placebo
Phase 2 Study of Roxadustat in Participants with Anemia and Chronic Kidney Disease Not Requiring Dialysis
  • Chronic Kidney

  • Disease •Anemia

  • FibroGen

  • Astellas Pharma Inc

24 NCT01414075 Drug: Roxadustat
Drug: Oral Iron
Drug: IV Iron
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
  • Dialysis

  • Anemia

  • FibroGen

  • Astellas Pharma Inc

25 NCT01376063 Drug: FG-4592 Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
  • Healthy Adult

  • Subjects

  • FibroGen

26 NCT01596855 Drug: FG-4592
Drug: Epoetin Alfa
Study of FG-4592 in Subjects with End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
  • Anemia in the End

  • Stage Renal

  • Disease

  • FibroGen

  • Ruijin Hospital

27 NCT01599507 Drug: FG-4592
Drug: Placebo
Study of FG-4592 in Subjects with Chronic Kidney Disease in China
  • Anemia in Chronic

  • Kidney Disease

  • FibroGen

28 NCT02652806 Drug: FG-4592
Drug: Epoetin Alfa
FG-4592 for Treatment of Anemia in Subjects with Chronic Kidney Disease
  • Anemia

  • FibroGen

29 NCT02652819 Drug: FG-4592
Drug: Placebo
FG-4592 for Treatment of Anemia in Subjects with Chronic Kidney Disease Not on Dialysis
  • Anemia

  • FibroGen

30 NCT02988973 Drug: Roxadustat
Drug: DA
A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients with Anemia
  • Chronic Kidney

  • Disease

  • Astellas Pharma

  • Inc •FibroGen

31 NCT02780726 Drug: Roxadustat A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease
Patients With Anemia
  • Peritoneal Dialysis

  • Chronic Kidney Disease Patients

  • With Anemia

  • Astellas Pharma

  • Inc •FibroGen

32 NCT02780141 Drug: Roxadustat A Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent (ESA)-Naive
Hemodialysis Chronic Kidney Disease Patients with Anemia
  • ESA-naive

  • Hemodialysis

  • Chronic Kidney

  • Disease Patients

  • With Anemia

  • Astellas Pharma

  • Inc

  • FibroGen

33 NCT02964936 Drug: Roxadustat A Study of Intermittent Oral Dosing of ASP1517 in ESA untreated Chronic Kidney Disease Patients with Anemia
  • Chronic Kidney

  • Disease

  • Astellas Pharma

  • Inc •FibroGen

34 NCT02779764 Drug: Roxadustat A Long-Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia Converted From Erythropoiesis Stimulating Agent (ESA) Treatment
  • Hemodialysis

  • Patients With Renal Anemia

  • Astellas Pharma

  • Inc

  • FibroGen

35 NCT01083888 Drug: Roxadustat ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
  • Anemia

  • Hemodialysis

  • Renal Impairment

  • Astellas Pharma

  • Inc

36 NCT02952092 Drug: Roxadustat
Drug: Darbepoetin alfa
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia
  • Hemodialysis

  • Chronic Kidney

  • Disease Patients

  • With Anemia

  • Astellas Pharma

  • Inc

  • FibroGen

37 NCT00978198 Drug: ASP1517(Roxadustat)
Drug: Placebo
Safety, Tolerability, and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
  • Healthy Volunteers

  • Astellas Pharma

  • Inc

38 NCT01888445 Drug: Roxadustat
Drug: darbepoetin alfa
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic
Kidney Disease Patients with Anemia Compared With Darbepoetin as a Reference Drug
  • Renal Anemia

Associated With Chronic Renal
  • Failure (CRF)

  • Astellas Pharma

  • Inc