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NCT05295784
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
Phase 1 trial testing Caffeine citrate in Acute Kidney Injury. Withdrawn.
8 May 2024
Quick facts
| Lead sponsor | University of Arkansas |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Start date | 8 May 2024 |
| Primary completion | 8 May 2024 |
| Estimated completion | 8 May 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Caffeine citrate — full drug profile →
Conditions studied
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
- Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →
- Caffeine — all drugs for Caffeine →
Sponsor
University of Arkansas
Who can join
Adults 0 Hours to 24 Hours, any sex, with Acute Kidney Injury or Hypoxic-Ischemic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653 -
Ferroptosis: A Promising Therapeutic Target for Neonatal Hypoxic-Ischemic Brain Injury.
Peeples ES, Genaro-Mattos TC. · · 2022 · cited 41× · PMID 35806425 · DOI 10.3390/ijms23137420 -
Lipocalin 2-not only a biomarker: a study of current literature and systematic findings of ongoing clinical trials.
Asaf S, Maqsood F, Jalil J, Sarfraz Z, et al · · 2023 · cited 38× · PMID 36529828 · DOI 10.1007/s12026-022-09352-2 -
Pharmacological Therapies for Consequences of Perinatal Hypoxic-Ischemic Brain Injury: Where Are We Now?
Gebala P, Janowska J, Sypecka J. · · 2025 · PMID 41155490 · DOI 10.3390/ijms262010200
Verify or expand the search:
- PubMed search for NCT05295784
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Caffeine citrate
Trials testing the same drug.
- NCT06972108 — CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO) · Phase 2 · not yet recruiting
- NCT06821698 — To Determine the Effect of KP-001 on Rosuvastatin, Caffeine PK and the Effect of Fluvoxamine on KP-001 PK in Volunteers · Phase 1 · completed
- NCT06097767 — the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy · EARLY_PHASE1 · unknown
- NCT06026163 — Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress · Phase 2, PHASE3 · recruiting
- NCT05574400 — The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study · Phase 2 · recruiting
Other recruiting trials for Acute Kidney Injury
Currently open trials in the same condition.
- NCT07273838 — Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome · Phase 2 · recruiting
- NCT07262320 — Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America · recruiting
- NCT07351149 — Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery · recruiting
- NCT07215702 — A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kid · Phase 2 · recruiting
- NCT06654193 — Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury · Phase 1, PHASE2 · recruiting
Other University of Arkansas trials
Trials by the same sponsor.
- NCT07029776 — MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma · Phase 2 · not yet recruiting
- NCT07341399 — Essential Amino Acid Supplementation in Adult Spinal Deformity Patients · NA · not yet recruiting
- NCT07071766 — Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment · NA · recruiting
- NCT05823727 — Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing Afte · NA · recruiting
- NCT06604065 — Essential Amino Acids and Parkinsons Disease · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05295784 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arkansas
- Last refreshed: 10 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05295784.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing