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

Hospital Central Sur de Pemex

Status and phase: Terminated; Phase 2

Conditions: Arthralgia; Kidney Failure, Chronic

Treatments: Drug: Diclofenac; Drug: Lumiracoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT01481610

PEMEX-805415-00-2

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

Lumiracoxib group

Experimental group

Description:

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.

Treatment:

Drug: Lumiracoxib

Diclofenac group

Active Comparator group

Description:

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.

Treatment:

Drug: Diclofenac