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

AbbVie Deutschland GmbH & Co. KG0 sites20 target enrollmentJuly 25, 2016

ConditionsDiabetic Nephropathy MedDRA version: 19.0Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetic Nephropathy
Sponsor: AbbVie Deutschland GmbH & Co. KG
Enrollment: 20
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 25, 2016

End Date

July 12, 2018

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

AbbVie Deutschland GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•Male subject 30 to 75 years of age, inclusive at the time of Screening.
•Subject has type 1 or 2 diabetes and is receiving treatment with at least one anti\-hyperglycemic medication and ACEi or ARB (RAS inhibitor).
•Subject has an eGFR \= 35 mL/min/1\.73 m2 with the CKD\-EPI formula and UACR \= 30 to \< 5,000 mg/g creatinine (\= 3\.4 mg/mmol and \< 565 mg/mmol).
•Subject is able to provide a semen specimen at the required intervals.
•Subject has a baseline sperm concentration \= 30 million per mL at Screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 18
•F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

•Subject has had treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids, glucocorticoids, ketoconazole, cyclosporine, or cancer chemotherapy within the 6 months prior to the initial screening visit or planned during the study.
•Subject is currently receiving or has received hormone replacement therapy within the last 6 months prior to the Screening Period.
•Subject has a history of severe peripheral edema or facial edema unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial screening visit.
•Subject has a history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring either oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema).
•Subject has a 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.Subject has a 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.