Prevention of Cisplatin-induced Nephrotoxicity

NCT06196853 | Not Yet Recruiting Phase 2

• 1 other identifier: 4639141
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Renal Tubulopathy

Keywords

Acute Kidney Injury; Chemotherapy induced kidney related complication

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glomerular filtration rate

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

  Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin

Secondary Outcomes (1)

• Renal tubular biomarkers

  Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin

Study Arms (2)

Control

NO INTERVENTION

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

Treatment

EXPERIMENTAL

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

Drug: Aminophylline

Interventions

Aminophylline DRUG

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

Treatment

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age under 18 years old
• Oncology patients who receive cisplatin-based therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital, Mahidol university

Bangkok, 10700, Thailand

Location

Related Publications (4)

• 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.

  PMID: 33805488 BACKGROUND

• 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.

  PMID: 16038872 BACKGROUND

• 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.

  PMID: 33192231 BACKGROUND

• 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.

  PMID: 15590762 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Aminophylline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Anirut Pattaragarn, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anirut Pattaragarn, MD

CONTACT

66816651020; apattaragarn@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)