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Atrasentan Spermatogenesis and Testicular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02118714
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 21, 2014
Last Update Posted Date August 1, 2018
Actual Study Start Date  ICMJE April 7, 2015
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
Proportion of subjects who have a sperm concentration < 15 million per mL [ Time Frame: Up to 26 weeks ]
Duplicate semen samples will be collected.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02118714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Change in estradiol [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in semen volume [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observation Periods.
  • Change in Lutenizing Hormone (LH) [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in Follicle Stimulating Hormone (FSH) [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in serum testosterone [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in sperm concentration [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observational Periods. Sperm concentration will be calculated as measure of the number sperm per milliliter of semen.
  • Change in inhibin B [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in sperm motility [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observation Periods.
  • Change in sperm morphology [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis.
  • Proportion of subjects who enter the Observation Period and do not return to within 15% of Week 0 by 52 weeks after treatment discontinuation [ Time Frame: Up to 52 weeks ]
    Duplicate semen samples will be collected during the Observational Period. Sperm concentration will be calculated as measure of the number sperm per milliliter of semen.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
  • Proportion of subjects who enter the Observation Period and do not return to within 15% of Week 0 by 52 weeks after treatment discontinuation [ Time Frame: Up to 52 weeks ]
    Duplicate semen samples will be collected during the Observational Period. Sperm concentration will be calculated as measure of the number sperm per milliliter of semen.
  • Change in sperm motility [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observation Periods.
  • Change in serum testosterone [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in estradiol [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in Lutenizing Hormone (LH) [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in Follicle Stimulating Hormone (FSH) [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in inhibin B [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Serum hormones levels will be tested during the Treatment and Observational Periods.
  • Change in sperm morphology [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis.
  • Change in semen volume [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observation Periods.
  • Change in sperm concentration [ Time Frame: From Week 0 to Week 26 and up to Week 52 after the end of treatment ]
    Duplicate semen samples will be collected during the Treatment and Observational Periods. Sperm concentration will be calculated as measure of the number sperm per milliliter of semen.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atrasentan Spermatogenesis and Testicular Function
Official Title  ICMJE A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function
Brief Summary This study is being conducted to evaluate the effects of Atrasentan on sperm production and the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Nephropathy
  • Diabetes
Intervention  ICMJE Drug: Atrasentan
Atrasentan
Study Arms  ICMJE Experimental: Atrasentan
Atrasentan daily (QD) for 26 weeks
Intervention: Drug: Atrasentan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 12, 2018
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males 30 to 75 years of age
  • Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB) (renin-angiotensin system [RAS] inhibitor)
  • Estimated Glomerular Filtration Rate (eGFR) equal to or greater than 35 mL/min with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula and Urine Albumin-to-Creatinine Ratio (UACR) equal to or greater than 30 and less than 5,000 mg/g creatinine.
  • Able to provide a semen specimen at the required intervals.
  • Baseline sperm concentration equal to or greater than 30 million per mL.

Exclusion Criteria:

  • Treatment with hormone suppressive agents or cancer chemotherapy within the past 6 months or planned during the study.
  • History of severe peripheral edema or facial edema unrelated to trauma or history of myxedema in the prior 4 weeks prior to screening.
  • History of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy.
  • Documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
  • Currently receiving or has received hormone replacement therapy within 6 months prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 75 Years   (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 Germany,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02118714
Other Study ID Numbers  ICMJE M12-919
2016-000722-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP