evaluation of the nephroprotective efficacy of oral theophylline in patients treated with cisplatin
Conditions
Interventions
Trade Name: Theophyllin retard-ratiopharm
Pharmaceutical Form: Capsule*
INN or Proposed INN: Theophyllin
CAS Number: 58-55-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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% | — |
Countries
Germany
Outcome results
None listed