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

Phase 2

Terminated

• Conditions: Kidney Failure, Chronic; Arthralgia
• Interventions: Drug: Lumiracoxib; Drug: Diclofenac

• Registration Number: NCT01481610
• Lead Sponsor: Hospital Central Sur de Pemex

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 compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-29
• Study Start: 2012-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumiracoxib group	Lumiracoxib	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.
Diclofenac group	Diclofenac	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.

Primary Outcome Measures

Name	Time	Method
Change in GFR	Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient	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).

Secondary Outcome Measures

Name	Time	Method
Use of rescue medication	Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose)	Proportion of patients in each group who required rescue analgesic drugs at the end of the study.
Subjective improvement in pain	Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose)	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.

Trial Locations

Locations (1)

Hospital Central Sur de Alta Especialidad PEMEX; 🇲🇽 Mexico City, DF, Mexico