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Dear Sirs / Madames
I am pharmacist and I am doing research about patients with renal failure.
During my investigation I have faced with a vague definition for stable or progressive renal failure!!!
I would like to ask you what is the exact meaning of stable or progressive renal failure.
In fact what are the exact criteria to judge some patients have STABLE RENAL FAILURE or not!
Fluctuation of GFR is the matter of concern in this matter? if YES, through which period of time and with which variance we can judge some body has STABLE or PROGRESSIVE renal failure? I would be appreciated if you care to help me in this matter.
Thanks in advance
Sincerely yours
Farshad K P.S: I need to know this definition in order to clarify inclusion criteria for recruiting patients in some investigation by limitation of STABLE RENAL STATUS! AND because in treatment with some drugs stability of renal function should be considered in respect to risk of alteration in pharmacokinetic of the drug and risk of accumulation!
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The following message was posted to: PharmPK
Dear Farshad,
There is an FDA guidance document on "Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling" which I'm sure you would find very useful. The original version (1998) and latest draft (2010) specify ways of categorising renal status (based on estimated GFR and/or creatinine clearance) and should help direct your study design. Both can be easily downloaded from the FDA website.
Kind regards,
Mark
Mark Baird
Drug Metabolism & Pharmacokinetics
Aptuit
Research Avenue South,
Heriot Watt University Research Park,
Riccarton, Edinburgh, EH14 4AP
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