---
title: Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
nct_id: NCT01481610
overall_status: TERMINATED
phase: PHASE2
sponsor: Hospital Central Sur de Pemex
study_type: INTERVENTIONAL
primary_condition: Kidney Failure, Chronic
countries: Mexico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01481610.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01481610"
ct_last_update_post_date: 2013-02-13
last_seen_at: "2026-05-12T06:07:56.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

**Official Title:** 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

**NCT ID:** [NCT01481610](https://clinicaltrials.gov/study/NCT01481610)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Interim analysis shows harma to one of the study arms.
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Hospital Central Sur de Pemex
- **Conditions:** Kidney Failure, Chronic, Arthralgia
- **Start Date:** 2012-01
- **Completion Date:** 2012-11
- **CT.gov Last Update:** 2013-02-13

## 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.

## Eligibility

- **Minimum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Lumiracoxib group** (EXPERIMENTAL) — 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** (ACTIVE_COMPARATOR) — 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.

## Interventions

- **Lumiracoxib** (DRUG) — 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.
- **Diclofenac** (DRUG) — 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 Outcomes

- **Change in GFR** _(time frame: 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 Outcomes

- **Use of rescue medication** _(time frame: Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose))_
- **Subjective improvement in pain** _(time frame: Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose))_

## Locations (1)

- Hospital Central Sur de Alta Especialidad PEMEX, Mexico City, Mexico City, Mexico

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital central sur de alta especialidad pemex|mexico city|mexico city|mexico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01481610.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01481610*  
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