Bixalomer

Generic Name: Bixalomer

Drug Type: Small Molecule

CAS Number: 851373-13-2

Unique Ingredient Identifier: 3160WY51LV

Background: Bixalomer is under investigation in clinical trial NCT01115985 (A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers).

Clinical Trials

Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

Completed

Conditions: Chronic Kidney Disease

Interventions: Drug: Bixalomer

First Posted Date: 2016-06-20

Last Posted Date: 2024-10-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 144

Registration Number: NCT02805348

Locations: 🇯🇵
Site JP00004, Gifu, Japan
🇯🇵
Site JP00001, Ibaraki, Japan
🇯🇵
Site JP00003, Kanagawa, Japan

and more 11 locations

Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Phase 2

Completed

Conditions: Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Interventions: Drug: ASP1585

First Posted Date: 2016-04-28

Last Posted Date: 2016-06-21

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 73

Registration Number: NCT02753894

Locations: 🇯🇵
Site JP00006, Ibaraki, Japan
🇯🇵
Site JP00008, Ibaraki, Japan
🇯🇵
Site JP00002, Miyagi, Japan

and more 8 locations

A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 Capsules

Phase 1

Completed

Conditions: Urine Phosphorus Excretion
Healthy

Interventions: Drug: ASP1585

First Posted Date: 2015-08-24

Last Posted Date: 2015-08-24

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 60

Registration Number: NCT02531204

Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

Completed

Conditions: Chronic Renal Failure

Interventions: Drug: bixalomer

First Posted Date: 2013-07-19

Last Posted Date: 2024-10-22

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 123

Registration Number: NCT01903213

A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Phase 3

Completed

Conditions: Renal Insufficiency
Chronic Kidney Disease
Hyperphosphatemia

Interventions: Drug: placebo
Drug: ASP1585

First Posted Date: 2012-12-05

Last Posted Date: 2014-07-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 163

Registration Number: NCT01742585

Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Phase 3

Completed

Conditions: Hyperphosphatemia
Chronic Kidney Disease
Renal Insufficiency

Interventions: Drug: ASP1585

First Posted Date: 2012-12-05

Last Posted Date: 2015-06-09

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 105

Registration Number: NCT01742611

A Study to Assess the Systemic Disposition of ASP1585 After Administration of 14C-labeled Drug

Phase 1

Completed

Conditions: Healthy
Pharmacokinetics of ASP1585

Interventions: Drug: ASP1585
Drug: 14C-Labeled ASP1585

First Posted Date: 2010-05-17

Last Posted Date: 2014-05-05

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 12

Registration Number: NCT01124747

A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy
Pharmacokinetics of Valsartan

Interventions: Drug: ASP1585
Drug: valsartan

First Posted Date: 2010-05-04

Last Posted Date: 2010-05-27

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 24

Registration Number: NCT01115972

A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy
Pharmacokinetics of Enalapril

Interventions: Drug: ASP1585
Drug: enalapril

First Posted Date: 2010-05-04

Last Posted Date: 2010-05-27

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 24

Registration Number: NCT01115946

A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy
Pharmacokinetics of Atorvastatin

Interventions: Drug: ASP1585
Drug: atorvastatin

First Posted Date: 2010-05-04

Last Posted Date: 2010-05-27

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 24

Registration Number: NCT01115985

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