Back to resultsAtrasentan Spermatogenesis and Testicular Function
Primary Purpose
Nephropathy, Diabetes
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atrasentan
Sponsored by
About this trial
This is an interventional other trial for Nephropathy focused on measuring Diabetic Nephropathies, Kidney Diseases, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
Eligibility 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/1.73 m^2 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 6 months prior to the initial screening visit 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.
Sites / Locations
- Alliance Research Centers /ID# 125945
- Frank Clark Urology Center /ID# 147794
- Research by Design, LLC /ID# 160784
- Southern IL Univ School of Med /ID# 129010
- Crescent City Clinical Res Ctr /ID# 150989
- Tulane Univ /ID# 130308
- Albany Medical College /ID# 131068
- Urologic Consultants of Southeastern Pennsylvania /ID# 124277
- Eastern Virginia Med School /ID# 153740
- Charite Research Organisation GmbH /ID# 154264
- Ospedale S. Carlo Borromeo /ID# 151672
- SCDU Nefrologia e dialisi-CMID /ID# 151673
- Hospital Universitario Reina S /ID# 151692
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atrasentan
Arm Description
Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks
Outcomes
Primary Outcome Measures
Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26
Percentage of Subjects with a Sperm Concentration < 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Secondary Outcome Measures
Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period
The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening).
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
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. A positive change from baseline indicates an improved sperm morphology.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone.
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02118714
Brief Title
Atrasentan Spermatogenesis and Testicular Function
Official Title
A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 6, 2015 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to evaluate the effects of Atrasentan on sperm production and testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.
This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an Observational Period (up to an additional 52 weeks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy, Diabetes
Keywords
Diabetic Nephropathies, Kidney Diseases, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrasentan
Arm Type
Experimental
Arm Description
Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Atrasentan
Intervention Description
Atrasentan
Primary Outcome Measure Information:
Title
Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26
Description
Percentage of Subjects with a Sperm Concentration < 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Time Frame
Up to 26 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period
Description
The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.
Time Frame
Up to 52 weeks after the Treatment Period
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
Description
Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration.
Time Frame
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
Description
Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening).
Time Frame
From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
Description
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. A positive change from baseline indicates an improved sperm morphology.
Time Frame
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
Description
Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume.
Time Frame
From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
Description
Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone.
Time Frame
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
Description
Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol.
Time Frame
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
Description
Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone.
Time Frame
From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
Description
Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone.
Time Frame
From Week 0 to Treatment Week 26 and Observation Week 52
Title
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
Description
Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B.
Time Frame
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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/1.73 m^2 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 6 months prior to the initial screening visit 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Alliance Research Centers /ID# 125945
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653-3621
Country
United States
Facility Name
Frank Clark Urology Center /ID# 147794
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research by Design, LLC /ID# 160784
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Southern IL Univ School of Med /ID# 129010
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Crescent City Clinical Res Ctr /ID# 150989
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tulane Univ /ID# 130308
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Albany Medical College /ID# 131068
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania /ID# 124277
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004-1017
Country
United States
Facility Name
Eastern Virginia Med School /ID# 153740
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Charite Research Organisation GmbH /ID# 154264
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Ospedale S. Carlo Borromeo /ID# 151672
City
Milan
ZIP/Postal Code
20153
Country
Italy
Facility Name
SCDU Nefrologia e dialisi-CMID /ID# 151673
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Hospital Universitario Reina S /ID# 151692
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
http://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
Atrasentan Spermatogenesis and Testicular Function
We'll reach out to this number within 24 hrs