New study checks if kidney disease changes cancer drug safety
NCT ID NCT04953897
First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 35 times
Summary
This early-stage study tests an oral cancer drug (decitabine and cedazuridine) in 18 adults with acute myeloid leukemia, myelodysplastic syndromes, or solid tumors. Half have severe kidney impairment, half have normal kidneys. Researchers measure how the drug moves through the body and check for side effects over about 8 weeks. The goal is to see if the drug is safe and works the same in people with kidney problems.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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BIO1
WITHDRAWNVilnius, Lithuania
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Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
RECRUITINGWroclaw, 51-162, Poland
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Complex Oncology Center - Plovdiv - Base II
WITHDRAWNPlovdiv, Bulgaria
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Erebuni Medical Center
RECRUITINGYerevan, Armenia
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Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders)
RECRUITINGYerevan, Armenia
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Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology)
RECRUITINGYerevan, Armenia
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Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept)
RECRUITINGMurcia, 30120, Spain
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Hospital Clínico Universitario Virgen de la Arrixaca (Solid Tumor Dept)
RECRUITINGMurcia, Spain
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Hospital Universitari Arnau de Vilanova
RECRUITINGLleida, Spain
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Hospital Universitari Dexeus - Grupo Quirónsalud
WITHDRAWNBarcelona, Spain
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Hospital Universitari i Politècnic La Fe
TERMINATEDValencia, Spain
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Hospital Universitario 12 de Octubre
WITHDRAWNMadrid, Spain
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Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu
RECRUITINGBucharest, 22328, Romania
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Institutul Oncologic Prof. Dr. Ion Chiricuta
RECRUITINGCluj-Napoca, 400015, Romania
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MD Anderson
RECRUITINGHouston, Texas, 77030, United States
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National Center of Oncology Named After V.A. Fanarjyan
RECRUITINGYerevan, Armenia
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START Barcelona - Hospital HM Nou Delfos
RECRUITINGBarcelona, 8023, Spain
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START Madrid - CIOCC - HM Sanchinarro
RECRUITINGMadrid, 28050, Spain
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START Madrid - Hospital Universitario Fundación Jiménez Díaz
RECRUITINGMadrid, 28040, Spain
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START Rioja - Hospital de San Pedro
RECRUITINGLa Rioja, 26006, Spain
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Summit Clinical Research s.r.o
RECRUITINGBratislava, 831 01, Slovakia
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
oral decitabine and cedazuridine (ASTX727)
What this could lead to
If successful, this study could show that the drug is safe and works similarly in patients with severe kidney impairment, allowing them to receive this treatment.
What could go wrong
This is a very early (Phase 1b), small study with only 18 participants. It focuses on drug levels and safety, not on curing the cancer. Results may not apply to all patients.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.