Kidney Failure, ChronicPhase 2NCT01481610
Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
A Phase 2 study testing Lumiracoxib and Diclofenac in people with Kidney Failure, Chronic and Arthralgia, run by Hospital Central Sur de Pemex at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Arthralgia
- What is being tested?
- Lumiracoxib and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Sur de Alta Especialidad PEMEX
Mexico City, Mexico City, 14140
About this study
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
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.
- Conditions
- Kidney Failure, Chronic, Arthralgia
- Being tested
- Lumiracoxib, Diclofenac
- Keywords
- Kidney Failure, Chronic, Arthralgia, NSAID, Diclofenac, Lumiracoxib, Safety
- Medical subject headings
- Kidney Failure, Chronic, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiracoxibDrug
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.
DiclofenacDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lumiracoxib |
| 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. Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (2)
Use of rescue medication
Proportion of patients in each group who required rescue analgesic drugs at the end of the study.
Measured: 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.
Measured: Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Interim analysis shows harma to one of the study arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central Sur de Pemex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Molina-Calzada, Hospital Central Sur de Pemex
- Investigators
- Carlos Molina-Calzada, M.D., Principal investigator, Petroleos Mexicanos - Servicios de SaludAlejandro Arce-Salinas, M.D., Study director, Petroleos Mexicanos - Servicios de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481610
- Sponsor's protocol ID
- PEMEX-805415-00-2
- Status last verified
- Feb 2013
- First submitted
- 23 Nov 2011
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01481610
- Acronym / sponsor ID
- PEMEX-805415-00-2
- Conditions
- Kidney Failure, Chronic, Arthralgia
- Keywords
- Kidney Failure, Chronic, Arthralgia, NSAID, Diclofenac, Lumiracoxib, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis shows harma to one of the study arms.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital Central Sur de PemexUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumiracoxib group | Experimental | Drug: LumiracoxibPatients 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 | Drug: DiclofenacPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumiracoxibPatients 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. | Drug | Lumiracoxib group |
| DiclofenacPatients 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 group |
Primary outcome
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).
2 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)
Results and safety
The study was stopped early (reason given: Interim analysis shows harma to one of the study arms.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Molina-Calzada, M.D. principal investigator
Petroleos Mexicanos - Servicios de Salud
Alejandro Arce-Salinas, M.D. study director
Petroleos Mexicanos - Servicios de Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumiracoxib and Diclofenac in people with Kidney Failure, Chronic and Arthralgia, run by Hospital Central Sur de Pemex at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis shows harma to one of the study arms.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.