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Tyrosine Kinase Inhibitor

Gilteritinib for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 and at the following postdose time points on 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24,48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312 hour(s) and at the end of study (maximum: day 23)
Awards & highlights

Study Summary

This trial will study how gilteritinib is processed by the body in patients with different levels of kidney function, as well as any side effects experienced.

Eligible Conditions
  • Kidney Failure
  • Pharmacokinetics of ASP2215
  • Gilteritinib
  • Normal Kidney Function

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 and at the following postdose time points on 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24,48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312 hour(s) and at the end of study (maximum: day 23)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 and at the following postdose time points on 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24,48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312 hour(s) and at the end of study (maximum: day 23) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK of gilteritinib in plasma: Apparent clearance (CL/F)
PK of gilteritinib in plasma: Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
PK of gilteritinib in plasma: Area under the concentration-time curve from the time of dosing to the last measurable concentration (unbound) (AUClast, u)
+4 more
Secondary outcome measures
Number of participants with Treatment Emergent Adverse Events (TEAEs)

Side effects data

From 2018 Phase 1 & 2 trial • 265 Patients • NCT02014558
40%
Anaemia
40%
Nausea
20%
Blood thyroid stimulating hormone increased
20%
Leukocytosis
20%
Bacteraemia
20%
Hypothyroidism
20%
Constipation
20%
Abdominal pain
20%
Asthenia
20%
Generalised oedema
20%
Hypokalaemia
20%
Bone pain
20%
Platelet count decreased
20%
Neutrophil count decreased
20%
Cough
20%
Lethargy
20%
Presyncope
20%
Hot flush
20%
Hyperglycaemia
20%
Lip infection
20%
Acute myeloid leukaemia
20%
Vitreous detachment
20%
Vitreous floaters
20%
Oral pain
20%
Vomiting
20%
Fatigue
20%
Memory impairment
20%
Infusion related reaction
20%
Hypomagnesaemia
20%
Tremor
20%
Dry skin
20%
Haemorrhage intracranial
20%
Ear pain
20%
Vision blurred
20%
Proctalgia
20%
Blood alkaline phosphatase increased
20%
Hypophosphataemia
20%
Dysaesthesia
20%
Urinary incontinence
20%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gilterinib 20 mg in Escalation Phase
Gilterinib 40 mg in Escalation Phase
Gilterinib 80 mg in Escalation Phase
Gilterinib 120 mg in Escalation Phase
Gilterinib 200 mg in Escalation Phase
Gilterinib 300 mg in Escalation Phase
Gilterinib 450 mg in Escalation Phase
Gilterinib 20 mg in Expansion Phase
Gilterinib 40 mg in Expansion Phase
Gilterinib 80 mg in Expansion Phase
Gilterinib 120 mg in Expansion Phase
Gilterinib 200 mg in Expansion Phase
Gilterinib 300 mg in Expansion Phase

Trial Design

2Treatment groups
Experimental Treatment
Group I: Gilteritinib (Severe Renal Impairment)Experimental Treatment1 Intervention
Participants with severe renal impairment received a single oral dose of 20 milligrams (mg) of gilteritinib on day 1, under fasting conditions.
Group II: Gilteritinib (Normal Renal Function)Experimental Treatment1 Intervention
Participants with normal renal function received a single oral dose of 20 mg of gilteritinib on day 1, under fasting conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
2014
Completed Phase 2
~560

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,069 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,064,202 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
2021. "A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04699877.
~4 spots leftby Apr 2025
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