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Atrasentan Spermatogenesis and Testicular Function

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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

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.

Condition or disease Intervention/treatment Phase
Nephropathy Diabetes Drug: Atrasentan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function
Actual Study Start Date : April 7, 2015
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : July 12, 2018

Arm Intervention/treatment
Experimental: Atrasentan
Atrasentan daily (QD) for 26 weeks
Drug: Atrasentan
Atrasentan




Primary Outcome Measures :
  1. Proportion of subjects who have a sperm concentration < 15 million per mL [ Time Frame: Up to 26 weeks ]
    Duplicate semen samples will be collected.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118714


Locations
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United States, California
Alliance Research Centers /ID# 125945
Laguna Hills, California, United States, 92653-3621
Frank Clark Urology Center /ID# 147794
Santa Monica, California, United States, 90404
United States, Illinois
Research by Design, LLC /ID# 160784
Evergreen Park, Illinois, United States, 60805
Southern IL Univ School of Med /ID# 129010
Springfield, Illinois, United States, 62702
United States, Louisiana
Crescent City Clinical Res Ctr /ID# 150989
Metairie, Louisiana, United States, 70006
Tulane Univ /ID# 130308
New Orleans, Louisiana, United States, 70112
United States, New York
Albany Medical College /ID# 131068
Albany, New York, United States, 12208
United States, Pennsylvania
Urologic Consultants of Southeastern Pennsylvania /ID# 124277
Bala-Cynwyd, Pennsylvania, United States, 19004-1017
United States, Virginia
Eastern Virginia Med School /ID# 153740
Norfolk, Virginia, United States, 23507-1627
Germany
Charite Research Organisation GmbH /ID# 154264
Berlin, Germany, 10117
Italy
Ospedale S. Carlo Borromeo /ID# 151672
Milan, Italy, 20153
SCDU Nefrologia e dialisi-CMID /ID# 151673
Torino, Italy, 10154
Spain
Hospital Universitario Reina S /ID# 151692
Cordoba, Spain, 14004
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02118714     History of Changes
Other Study ID Numbers: M12-919
2016-000722-19 ( EudraCT Number )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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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

Keywords provided by AbbVie:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Atrasentan
Antineoplastic Agents
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action