Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

Comparison of the Effects on Renal Function of Lumiracoxib and Diclofenac in Patients With Chronic Kidney Failure K/DOQI Stage III at the HCSAE PEMEX

The purpose of this study is to determine whether the use of lumiracoxib in this particular population is associated with a decrease in glomerular filtration rate (GFR) compared to diclofenac; and to compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.

Inclusion Criteria:

• chronic joint pain, requiring analgesia
• pre-existing chronic kidney injury, stage K/DOQI III (GFR 30 - 59 ml/min)
• in a stable phase of CKD (i.e. not AKI, not hospitalized)
• without contraindications for NSAID therapy
• who have signed an informed consent

Exclusion Criteria:

• having received any NSAID 2 weeks prior to study start
• history of / actual PUD
• patients with ESRD (K/DOQI IV, V or replacement therapy)
• history of hypersensitivity or allergies to any of the treatments
• history of / actual GI bleeding
• with impaired liver function tests
• using ACEI / ARB