Atrasentan Spermatogenesis and Testicular Function

AbbVie20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Nephropathy Diabetes

Interventions

AtrasentanDRUG

Atrasentan

Eligibility

Sex: MALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (13)

Alliance Research Centers /ID# 125945

Laguna Hills, California, United States

Frank Clark Urology Center /ID# 147794

Santa Monica, California, United States

Research by Design, LLC /ID# 160784

Outcomes

Primary Outcomes

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.

Time frame: Up to 26 weeks

Secondary Outcomes

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.

Time frame: Up to 52 weeks after the Treatment 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.

Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52

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).

Data from ClinicalTrials.gov

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Evergreen Park, Illinois, United States

Southern IL Univ School of Med /ID# 129010

Springfield, Illinois, United States

Crescent City Clinical Res Ctr /ID# 150989

Metairie, Louisiana, United States

Tulane Univ /ID# 130308

New Orleans, Louisiana, United States

Albany Medical College /ID# 131068

Albany, New York, United States

Urologic Consultants of Southeastern Pennsylvania /ID# 124277

Bala-Cynwyd, Pennsylvania, United States

Eastern Virginia Med School /ID# 153740

Norfolk, Virginia, United States

Charite Research Organisation GmbH /ID# 154264

Berlin, Germany

...and 3 more locations

Time frame: From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52

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.

Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52

Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume

Time frame: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52

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.

Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52

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.

Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52

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.

Time frame: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52

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.

Time frame: From Week 0 to Treatment Week 26 and Observation Week 52

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.

Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52