Prevention of Cisplatin-induced Nephrotoxicity

Phase 2

Not yet recruiting

• Conditions: Renal Tubulopathy; Acute Kidney Injury
• Interventions: Drug: Aminophylline

• Registration Number: NCT06196853
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Study Start: 2024-04-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Aminophylline	5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr. plus aminophylline.

Primary Outcome Measures

Name	Time	Method
creatinine and cystatin C-based glomerular filtration rate estimation	Baseline before cisplatin, and 24 hours and 5 days post cisplatin	Blood for creatinine and cystatin C
Radionuclide-based glomerular filtration rate measurement	Baseline before cisplatin and 5 days post cisplatin	Tc-DTPA renal radionuclide imaging

Secondary Outcome Measures

Name	Time	Method
Renal tubular biomarkers	Baseline before cisplatin, and 24 hours and 5 days post cisplatin	Urine for beta2 macroglobulin and N-acetyl-beta-D-glucosaminidase

Trial Locations

Locations (1)

Siriraj hospital, Mahidol university; 🇹🇭 Bangkok, Thailand