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Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

NCT05534620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-20

No results posted yet for this study

Summary

This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients. The study also aims to determine an appropriate safe dose of treosulfan, when patient's renal function is impaired. The participants of this study are undergoing allogenic hematopoietic stem cell transplantation for treatment of acute myeloid leukemia or myelodysplastic syndrome.

Conditions

  • Acute Myeloid Leukaemia (AML)
  • Myelodysplastic Syndrome (MDS)
  • Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Interventions

DRUG

Treosulfan

IV infusion

DRUG

Fludarabine

IV infusion

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Ute Eckenbach · SyntheractHCR

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-05-14
Completion
2025-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534620 on ClinicalTrials.gov