Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
This study has been completed.
Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT00865449
First received: March 17, 2009
Last updated: October 23, 2012
Last verified: March 2009
| Tracking Information | |||||
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| First Received Date ICMJE | March 17, 2009 | ||||
| Last Updated Date | October 23, 2012 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Peritoneal fibrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00865449 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis | ||||
| Official Title ICMJE | Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients | ||||
| Brief Summary | This is a double blind randomized controlled study to evaluate the effect of aldactone on peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on peritoneal fibrosis. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | End Stage Renal Disease | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Mexico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00865449 | ||||
| Other Study ID Numbers ICMJE | 08-590 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez | ||||
| Study Sponsor ICMJE | Instituto Nacional de Cardiologia Ignacio Chavez | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Instituto Nacional de Cardiologia Ignacio Chavez | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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