Monozentrische, randomisierte, placebo-kontrollierte Studie zur Evaluation der Nephroprotektion durch Theophyllin unter Cisplatin-haltiger Chemotherapie
- Conditions
- evaluation of the nephroprotective efficacy of oral theophylline in patients treated with cisplatin
- Registration Number
- EUCTR2005-004540-31-DE
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
patients with solide or non-solide tumors treated with cisplatin, age between 18 and 75 years, dose of cisplatin at least 50 mg/sqm on day 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
pretreatment with theophyllin within 3 days before randomization
coronar disease, instable angina pectoris
cardiac insufficiency (> stage NYHA II)
arrhythmia
hyperthyreosis
acute infection
insufficient liver function
hearing difficulty (ototoxicity > grade II according to WHO)
neurological disorder (PNP > grade II according to WHO)
known intolerability against theophyllin
pregnancy, lactation
known non-compliance
known disorder of miction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluation of the nephroprotective efficacy of oral theophylline in patients treated with cisplatin;Secondary Objective: ;Primary end point(s): GFR reduction of at least 20%
- Secondary Outcome Measures
Name Time Method