Clinical trial NCT02118714: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nephropathy
Diabetes
Keywords: Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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.

Primary outcomes:
measure: Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 52 weeks after the Treatment Period
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
timeFrame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
timeFrame: From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology
timeFrame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume
timeFrame: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone
timeFrame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol
timeFrame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)
timeFrame: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)
timeFrame: From Week 0 to Treatment Week 26 and Observation Week 52
measure: Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B
timeFrame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Alliance Research Centers /ID# 125945
state: California
city: Santa Monica
country: United States
facility: Frank Clark Urology Center /ID# 147794
state: California
city: Evergreen Park
country: United States
facility: Research by Design, LLC /ID# 160784
state: Illinois
city: Springfield
country: United States
facility: Southern IL Univ School of Med /ID# 129010
state: Illinois
city: Metairie
country: United States
facility: Crescent City Clinical Res Ctr /ID# 150989
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Univ /ID# 130308
state: Louisiana
city: Albany
country: United States
facility: Albany Medical College /ID# 131068
state: New York
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania /ID# 124277
state: Pennsylvania
city: Norfolk
country: United States
facility: Eastern Virginia Med School /ID# 153740
state: Virginia
city: Berlin
country: Germany
facility: Charite Research Organisation GmbH /ID# 154264
city: Milan
country: Italy
facility: Ospedale S. Carlo Borromeo /ID# 151672
city: Torino
country: Italy
facility: SCDU Nefrologia e dialisi-CMID /ID# 151673
city: Cordoba
country: Spain
facility: Hospital Universitario Reina S /ID# 151692
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: