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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Kidney Failure, Chronic, Arthralgia

Intervention / Treatment
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* Drug: Lumiracoxib
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumiracoxib group<br>Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day) for a period of maximum 10 days, but no shorter than 7 days. | Drug: Lumiracoxib<br>* Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day), for a period no longer than 10 days, but no shorter than 7 days.<br>|
| Active Comparator: Diclofenac group<br>Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days. | Drug: Diclofenac<br>* Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GFR | Magnitude of change in GFR (ml / min) as measured by creatinine clearance in urine over 24 hours, considering the initial and final value at the end of the study. Creatinine clearance will be measured twice: initially, prior to the first dose of medication (baseline), and again at the end of treatment (ie. 10 days after starting dose). | Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue medication | Proportion of patients in each group who required rescue analgesic drugs at the end of the study. | Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose) | 
| Subjective improvement in pain | Change in the subjective perception of pain, assessed with help of a validated Visual Analog Scale both prior to the start of treatment and again at the end of treatment. | Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Failure, Chronic, Arthralgia, NSAID, Diclofenac, Lumiracoxib, Safety