Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)
This study has been withdrawn prior to enrollment.
Sponsor:
Stromedix, Inc.
Information provided by:
Stromedix, Inc.
ClinicalTrials.gov Identifier:
NCT00878761
First received: April 6, 2009
Last updated: May 20, 2011
Last verified: May 2011
Tracking Information | |||||
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First Received Date ICMJE | April 6, 2009 | ||||
Last Updated Date | May 20, 2011 | ||||
Start Date ICMJE | September 2010 | ||||
Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety as measured by adverse events [ Time Frame: 25 weeks from first dosing (per cohort) ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00878761 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA) | ||||
Official Title ICMJE | Randomized Double-Blind, Placebo-Controlled, Single and Multiple Dose, Dose-Escalation Study of STX 100 in Renal Transplant Patients With Biopsy Proven Interstitial Fibrosis and Tubular Atrophy (IF/TA) | ||||
Brief Summary | This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single followed by multiple dose, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact of STX-100 on gene and protein expression for αvβ6 related and TGF-β-inducible genes (including tubulointerstitial injury, epithelial function, and IF/TA related genes) in renal transplant patients with biopsy. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Allograft Dysfunction | ||||
Intervention ICMJE | Biological: STX-100
SC, single dose followed by multiple dose |
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Study Arm (s) |
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Publications * | |||||
* 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 | Withdrawn | ||||
Estimated Enrollment ICMJE | 48 | ||||
Estimated Completion Date | December 2011 | ||||
Estimated Primary Completion Date | October 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 to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878761 | ||||
Other Study ID Numbers ICMJE | STX-002 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Bradley Maroni, MD, Stromedix, Inc | ||||
Study Sponsor ICMJE | Stromedix, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Stromedix, Inc. | ||||
Verification Date | May 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |