Prevention of Cisplatin-induced Nephrotoxicity

Sponsor
Mahidol University
Study ID
NCT06196853
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Renal Tubulopathy

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 9, 2024
Start date
Dec 1, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control
    5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr.
  • Experimental: Treatment
    5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr. plus aminophylline.

Primary Outcome Measure

Change from baseline in glomerular filtration rate [ Time Frame: Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin ]

Central Contacts

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