NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
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ClinicalTrials.gov Identifier: NCT01547897 |
Recruitment Status :
Completed
First Posted : March 8, 2012
Last Update Posted : February 24, 2014
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Sponsor:
TME Pharma AG
Information provided by (Responsible Party):
TME Pharma AG
Tracking Information | ||||
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First Submitted Date ICMJE | February 27, 2012 | |||
First Posted Date ICMJE | March 8, 2012 | |||
Last Update Posted Date | February 24, 2014 | |||
Study Start Date ICMJE | March 2012 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g) [ Time Frame: Change versus baseline after 12 weeks treatment ] ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria | |||
Official Title ICMJE | A Phase IIa Study to Characterize the Effects of CCL2 Inhibition With the Spiegelmer® NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria | |||
Brief Summary | Primary objective: - To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria Secondary objectives:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: NOX-E36
0.5 mg/kg study drug or placebo as SC injections twice a week
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Study Arms ICMJE |
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Publications * | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. | |||
* 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 | |||
Actual Enrollment ICMJE |
76 | |||
Original Estimated Enrollment ICMJE |
75 | |||
Actual Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Czech Republic, Germany, Hungary, Poland, Romania | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01547897 | |||
Other Study ID Numbers ICMJE | SNOXE36C301 2011-005710-11 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | TME Pharma AG | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | TME Pharma AG | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | TME Pharma AG | |||
Verification Date | September 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |