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.

Study Overview

• Status: Terminated
• Conditions: Arthralgia; Kidney Failure, Chronic
• Intervention / Treatment: Drug: Lumiracoxib; Drug: Diclofenac

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • DF
    • Mexico City, DF, Mexico, 14140
      • Hospital Central Sur de Alta Especialidad PEMEX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumiracoxib group; 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; 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.
Active Comparator: Diclofenac group; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hospital Central Sur de Pemex
• Investigators: Principal Investigator: Carlos Molina-Calzada, M.D., Petroleos Mexicanos - Servicios de Salud; Study Director: Alejandro Arce-Salinas, M.D., Petroleos Mexicanos - Servicios de Salud

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 23, 2011
• First Submitted That Met QC Criteria: November 25, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Safety; Kidney Failure, Chronic; Arthralgia; NSAID; Diclofenac; Lumiracoxib
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Renal Insufficiency, Chronic; Arthralgia; Kidney Failure, Chronic; Renal Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Diclofenac; Lumiracoxib
• Other Study ID Numbers: PEMEX-805415-00-2