Bosutinib In Subjects With Renal Impairment

Status Completed

Clinical Trial Summary

This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01233882
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 1
Start date	December 2010
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT05056727` - A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia	Phase 3
Withdrawn	`NCT01655186` - A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus	Phase 2
Completed	`NCT03481686` - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections	N/A
Active, not recruiting	`NCT03672110` - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen	Phase 3
Enrolling by invitation	`NCT02237534` - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia	Phase 4
Completed	`NCT02126293` - Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant	Phase 3
Terminated	`NCT01533545` - Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients	N/A
Completed	`NCT03280615` - Omega 3 Fatty Acids in Patients With Chronic Renal Disease	Phase 3
Completed	`NCT04498156` - Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)
Recruiting	`NCT04020328` - Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency	Phase 4
Recruiting	`NCT06366529` - Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction
Active, not recruiting	`NCT04876963` - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed	`NCT03836508` - Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis	N/A
Completed	`NCT03250715` - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure	N/A
Completed	`NCT03577249` - Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation	Phase 2/Phase 3
Completed	`NCT01975818` - Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934	Phase 2
Active, not recruiting	`NCT05766644` - App-based Education Program for CKD	N/A
Active, not recruiting	`NCT02791880` - Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Recruiting	`NCT02947750` - Neurovascular Transduction During Exercise in Chronic Kidney Disease	Phase 2
Terminated	`NCT02286258` - Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)	Phase 1/Phase 2