Prevention of Cisplatin-induced Nephrotoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Acute Kidney Injury Renal Tubulopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr. plus aminophylline.

Group Type EXPERIMENTAL

Aminophylline

Intervention Type DRUG

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

Interventions

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Aminophylline

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

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No