Status:
TERMINATED
Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
Lead Sponsor:
Hospital Central Sur de Pemex
Conditions:
Kidney Failure, Chronic
Arthralgia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01481610
Start Date
January 1 2012
End Date
November 1 2012
Last Update
February 13 2013
Active Locations (1)
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1
Hospital Central Sur de Alta Especialidad PEMEX
Mexico City, Mexico City, Mexico, 14140