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NCT Number: NCT06196853

Prevention of Cisplatin-induced Nephrotoxicity

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Siriraj hospital, Mahidol university

Bangkok, 10700, Thailand

Location contact

Anirut Pattaragarn

PRINCIPAL_INVESTIGATOR

Kleebsabai Sanpakit

SUB_INVESTIGATOR

Pantitra Montatipkul

SUB_INVESTIGATOR

Siriraj Institutional Review Board

CONTACT

[email protected]

+6624194322

Weerawadee Chandranipapongse

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminophylline

Drug

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

Primary outcomes

  1. Change from baseline in glomerular filtration rate

    Time frame: Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin

    Glomerular filtration rate is calculated using Cystatin C-creatinine-based equations. (ref. Kidney Int. 2012 Aug;82(4):445-53.)

Secondary outcomes

  1. Renal tubular biomarkers

    Time frame: Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin

    Urine for beta2 macroglobulin

Study contacts

Contact information is provided by the study sponsor or research team.

Anirut Pattaragarn, MD

CONTACT

[email protected]

66816651020

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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