Kidney TransplantPhase 2NCT01021943
Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
A Phase 2 study testing spironolactone in people with Kidney Transplant, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2009to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney Failure
- Age > 18
- Kidney transplant recipients
Who cannot join
- Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
- Kidney transplant performed more than one month from enrollment in the study
- Hyperkalemia (K> 5.5 meqL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors
- Conditions
- Kidney Transplant
- Being tested
- spironolactone, Placebo
- Keywords
- calcineurin inhibitors, fibrosis, spironolactone, Focus of the study is to assess if aldosterone blockade has an effect on interstitial fibrosis amongst kidney transplant recipients
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactoneDrug
Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
PlaceboDrug
Half of the subjects will be assigned to receive placebo for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months Receives: Drug: Placebo |
| spironolactone | Active comparator | Half of the subjects will be randomized to receive spironolactone for 6 months Receives: Drug: spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
Measured: 2 years
Secondary outcomes (2)
allograft function and proteinuria
Measured: 2 years
Fibrosis markers in kidney biopsies such as TGF-B
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021943
- Sponsor's protocol ID
- PT-26
- Status last verified
- Jul 2014
- First submitted
- 30 Nov 2009
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01021943
- Acronym / sponsor ID
- PT-26
- Conditions
- Kidney Transplant
- Keywords
- calcineurin inhibitors, fibrosis, spironolactone, Focus of the study is to assess if aldosterone blockade has an effect on interstitial fibrosis amongst kidney transplant recipients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- Nov 2009
- First posted
- 1 Dec 2009 (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 main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHalf of the subjects will be assigned to receive either spironolactone or placebo for 6 months |
| spironolactone | Active comparator | Drug: spironolactoneHalf of the subjects will be randomized to receive spironolactone for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney Failure
- Age > 18
- Kidney transplant recipients
Key exclusion criteria (3 listed)
- Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
- Kidney transplant performed more than one month from enrollment in the study
- Hyperkalemia (K> 5.5 meqL)
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 |
|---|---|---|
| spironolactoneHalf of the subjects will be assigned to receive 25 mg of spironolactone for 6 months | Drug | spironolactone |
| PlaceboHalf of the subjects will be assigned to receive placebo for 6 months | Drug | Placebo |
Primary outcome
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
Time frame: 2 years
2 secondary outcomes
allograft function and proteinuria
Time frame: 2 years
Fibrosis markers in kidney biopsies such as TGF-B
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 spironolactone in people with Kidney Transplant, run by Instituto Nacional de Cardiologia Ignacio Chavez 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 3 inclusion and 3 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: paused, as of the sponsor's last update on 24 Jul 2014. 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. Some participants in this study may receive a placebo. 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?
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?
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention) (time frame: 2 years). 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 24 Jul 2014.