The effects of Atrasentan on sperm production and the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy
- Conditions
- Diabetic NephropathyMedDRA version: 19.0Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2016-000722-19-DE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 20
• 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
F.1.3.1 Number of subjects for this age range 2
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the effect of Atrasentan on spermatogenesis and testicular function in men with diabetic nephropathy.;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects who have a sperm concentration < 15 million per mL during the 26-week Treatment Period;Timepoint(s) of evaluation of this end point: 26-week Treatment Period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • The proportion of subjects who enter the Observational Period and do not return to within 15% of baseline or above during the 52-week Observational Period.<br>• Change from baseline to each visit in sperm concentration.<br>• Change from baseline to each visit in each of the components of the semen analysis (sperm motility, sperm morphology, sperm count, semen volume).<br>• Change from baseline to each visit in serum testosterone, estradiol, LH, FSH, and inhibin B.<br> ;Timepoint(s) of evaluation of this end point: First secondary endpoint: 52-week Observational Period<br>Last three secondary endpoints: through-out the subject's participation