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

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Central Sur de Pemex
• Treatments: Diclofenac; Lumiracoxib

Criteria

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