title: Renal tolerance of gadolinium-DTPA/dimeglumine in patients with chronic renal failure.
abstract: Safety data for renal tolerance of gadolinium-DTPA(Gd-DTPA)/dimeglumine were evaluated in 21 patients (age: mean +/- standard deviation [SD], 58 +/- 12 years) with impaired renal function. The mean +/- SD serum creatinine level at baseline was 213 +/- 101 mumol/L (range, 89.2-551 mumol/L). Creatinine clearance at baseline averaged 34.5 +/- 19.2 mL/minute (range, 7.2-70 mL/minute). Gd-DTPA was injected at a dose of 0.1 mmol/kg body weight. Serum parameters (creatinine, sodium, and potassium) were determined before and 6, 24, 48, and 120 hours after administration of Gd-DTPA. Urinary parameters (N-acetyl-beta-D-glucosaminidase [beta-NAG], protein, and albumin) were determined before (spot urine sample) and after treatment for collection periods 0 to 3, 3 to 6, 6 to 12, 12 to 24, and 24 to 48 hours. A final spot urine sample was taken at 120 hours. There was no significant statistical change of serum creatinine level within the observation period, and there was no single patient matching the criteria of acute renal failure (increase of serum creatinine level of 88.4 mumol/L [1 mg/dL] or more within 48 hours after injection). Serum values of sodium and potassium levels remained unchanged. Beta-NAG was slightly increased 0 to 3 hours after injection, but returned to baseline values during the collection periods up to 120 hours. There was no increase of protein or albumin excretion. These preliminary results suggest Gd-DTPA has good renal tolerance in patients with pre-existing chronic renal failure.
authors.affiliation: Schering AG, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Haustein
authors.forename: H P
authors.initials: HP
authors.lastname: Niendorf
authors.forename: G
authors.initials: G
authors.lastname: Krestin
authors.forename: T
authors.initials: T
authors.lastname: Louton
authors.forename: G
authors.initials: G
authors.lastname: Schuhmann-Giampieri
authors.forename: W
authors.initials: W
authors.lastname: Clauss
authors.forename: W
authors.initials: W
authors.lastname: Junge
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003287:Contrast Media / Q000009:adverse effects* / Q000493:pharmacokinetics; D004338:Drug Combinations; D004361:Drug Tolerance; D005260:Female; D005682:Gadolinium / Q000009:adverse effects* / Q000493:pharmacokinetics; D019786:Gadolinium DTPA; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000378:metabolism*; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000009:adverse effects* / Q000493:pharmacokinetics; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects* / Q000493:pharmacokinetics; D004369:Pentetic Acid / Q000009:adverse effects* / Q000493:pharmacokinetics; D013997:Time Factors
chemical_list: D003287:Contrast Media; D004338:Drug Combinations; D009942:Organometallic Compounds; D008536:Meglumine; D004369:Pentetic Acid; D005682:Gadolinium; D019786:Gadolinium DTPA