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Not yet recruiting NCT06196853

Prevention of Cisplatin-induced Nephrotoxicity

Phase II / Phase III Interventional Acute Kidney Injury Renal Tubulopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aminophylline.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Renal Tubulopathy. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Nephroprotective Effects of Aminophylline in Pediatric Oncologic Patient on Cisplatin Based Chemotherapy; Double Blind Randomized Controlled Trial

Overview

The research design is a prospective, randomized, controlled clinical trial in children to study effect of aminophylline in preserving renal function in oncologic patient received cisplatin either combined with other CMT or used alone. The participants in both groups will receive standard protocol pre-cisplatin infusion which include hydration with 5%DNSS/2 with KCL and MgSO4 IV infusion. In the treatment group, the participants will receive aminophylline infusion in the first 24 hours along with cisplatin, followed by oral aminophylline oral three times daily orally for 4 consecutive days post cisplatin. The aminophylline serum level will be maintained at the therapeutic range 10-20 mg. The side effect of aminophylline including nausea, vomiting and ECG will be monitored. The collected data including urine volume, GFR (estimated by cystatin C-creatinine based equation and by radiopharmaceutical-Tc DTPA), and renal tubular biomarker (urine B2 macroglobulin and urine NGAL) will be collected at baseline before receiving cisplatin, 24 hours and 5 days post cisplatin.

Interventions

  • Drug Aminophylline
    Give aminophylline for 5 days to keep serum theophylline level 5-15 mg/dl

Primary outcome measures

  • Change from baseline in glomerular filtration rate [Time frame: Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin]
Secondary outcome measures (1)
  • Renal tubular biomarkers [Time frame: Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin]

Eligibility criteria

Inclusion criteria

  • Age under 18 years old
  • Oncology patients who receive cisplatin-based therapy

Exclusion criteria

  • Preexisting renal anomalies
  • Preexisting GFR less than 60 ml/min/1.73 m2
  • Contraindication of aminophylline including structural heart disease, arrhythmia, hyperthyroidism, chronic liver disease, epilepsy
  • Aminophylline use within 24 hours prior to study entry

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Siriraj hospital, Mahidol university — Bangkok

Publications

  • McSweeney KR, Gadanec LK, Qaradakhi T, Ali BA, Zulli A, Apostolopoulos V. Mechanisms of Cisplatin-Induced Acute Kidney Injury: Pathological Mechanisms, Pharmacological Interventions, and Genetic Mitigations. Cancers (Basel). 2021 Mar 29;13(7):1572. doi: 10.3390/cancers13071572. PMID 33805488
  • Sugawara M, Mochizuki T, Takekuma Y, Miyazaki K. Structure-affinity relationship in the interactions of human organic anion transporter 1 with caffeine, theophylline, theobromine and their metabolites. Biochim Biophys Acta. 2005 Aug 15;1714(2):85-92. doi: 10.1016/j.bbamem.2005.06.006. PMID 16038872
  • Alsaadoun S, Rustom F, Hassan HA, Alkhurais H, Aloufi M, Alzahrani S, Bakhsh S, Dalbhi SA. Aminophylline for improving acute kidney injury in pediatric patients: A systematic review and meta-analysis. Int J Health Sci (Qassim). 2020 Nov-Dec;14(6):44-51. PMID 33192231
  • Benoehr P, Krueth P, Bokemeyer C, Grenz A, Osswald H, Hartmann JT. Nephroprotection by theophylline in patients with cisplatin chemotherapy: a randomized, single-blinded, placebo-controlled trial. J Am Soc Nephrol. 2005 Feb;16(2):452-8. doi: 10.1681/ASN.2004030225. Epub 2004 Dec 8. PMID 15590762

Identifiers

NCT: NCT06196853 · 4639141

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗