Atrasentan Spermatogenesis and Testicular Function

Diabetes Clinical Trial

Official title:

A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118714
• Other study ID #: M12-919
• Secondary ID: 2016-000722-19
• Status: Completed
• Phase: Phase 2
• Start date: April 6, 2015
• Est. completion date: July 16, 2018

Study information

• Verified date: May 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 16, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Kidney Diseases
• Nephropathy

Intervention

Drug:
• Atrasentan
Atrasentan

Locations

Country	Name	City	State
Germany	Charite Research Organisation GmbH /ID# 154264	Berlin
Italy	Ospedale S. Carlo Borromeo /ID# 151672	Milan
Italy	SCDU Nefrologia e dialisi-CMID /ID# 151673	Torino
Spain	Hospital Universitario Reina S /ID# 151692	Cordoba
United States	Albany Medical College /ID# 131068	Albany	New York
United States	Urologic Consultants of Southeastern Pennsylvania /ID# 124277	Bala-Cynwyd	Pennsylvania
United States	Research by Design, LLC /ID# 160784	Evergreen Park	Illinois
United States	Alliance Research Centers /ID# 125945	Laguna Hills	California
United States	Crescent City Clinical Res Ctr /ID# 150989	Metairie	Louisiana
United States	Tulane Univ /ID# 130308	New Orleans	Louisiana
United States	Eastern Virginia Med School /ID# 153740	Norfolk	Virginia
United States	Frank Clark Urology Center /ID# 147794	Santa Monica	California
United States	Southern IL Univ School of Med /ID# 129010	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 26 weeks
Secondary	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.	Up to 52 weeks after the Treatment Period
Secondary	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.	From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Secondary	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).	From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
Secondary	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.	From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Secondary	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.	From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
Secondary	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.	From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Secondary	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.	From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Secondary	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.	From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
Secondary	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.	From Week 0 to Treatment Week 26 and Observation Week 52
Secondary	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.	From Week 0 up to Treatment Period Week 26 and Observation Period Week 52