Prevention of Cisplatin-induced Nephrotoxicity

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196853
• Other study ID #: 4639141
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2023
• Source: Mahidol University
• Contact: Anirut Pattaragarn, MD
• Phone: 66816651020
• Email: apattaragarn[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj hospital, Mahidol university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creatinine and cystatin C-based glomerular filtration rate estimation	Blood for creatinine and cystatin C	Baseline before cisplatin, and 24 hours and 5 days post cisplatin
Primary	Radionuclide-based glomerular filtration rate measurement	Tc-DTPA renal radionuclide imaging	Baseline before cisplatin and 5 days post cisplatin
Secondary	Renal tubular biomarkers	Urine for beta2 macroglobulin and N-acetyl-beta-D-glucosaminidase	Baseline before cisplatin, and 24 hours and 5 days post cisplatin