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Clinical study of proton pump inhibitors in ameliorating renal toxicity induced by cisplatin

Clinical study of proton pump inhibitors in ameliorating renal toxicity induced by cisplatin

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050436
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor

Interventions

Cisplatin group:Nil
Cisplatin + proton pump inhibitor group:Nil

Sponsors

Ankang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Solid tumor patients aged over 18 years (including 18 years old, subject to the time of signing the informed consent form) who need to use cisplatin chemotherapy; 2. Fully understand the purpose, nature, method and possible adverse reactions of the research, and voluntarily sign a written informed consent; 3. Not pregnant or breastfeeding; 4. No change in chronic disease drug treatment within 2 weeks before the start of the study; 5. Baseline serum creatinine clearance >=60 mL/min/1.73m^2.

Exclusion criteria

Exclusion criteria: 1. Allergic to cisplatin or contraindications to chemotherapy; 2. Allergy to benzimidazoles or other contraindications to proton pump inhibitors; 3. The use of contrast agents or the use of nephrotoxic drugs (such as aminoglycosides, amphotericin B, etc.) within 1 week before the start of the study; 4. Patients diagnosed with renal cancer or abnormal baseline serum creatinine and baseline blood urea nitrogen; 5. ECOG PS >=2 points; 6. Patients using OCT2 substrates or inhibitors; 7. Abnormal liver function indicators (ALT or AST>=3xULN); 8. Those with a history of nephrectomy; 9. Participants with history of organ transplantation or renal dialysis or participants who need organ transplantation or kidney dialysis; 10. Patients with chronic heart failure who cannot receive more than 1L of fluid; 11. Participated in other drug clinical studies within 3 months before the start of the study; 12. Any other situation that the investigator believes may affect the patient's following the research protocol, or the patient's participation in the research may affect the research results or their own safety.

Design outcomes

Primary

MeasureTime frame
Serum creatinine;

Secondary

MeasureTime frame
Blood urea nitrogen;

Countries

China

Contacts

Public ContactYuan Ziqingyun

Ankang People's Hospital

yuanziqingyun@163.com+86 15319698628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026