Phase 2
N=20
Atrasentan Spermatogenesis and Testicular Function
Nephropathy · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02118714 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
May 2019
Primary outcome: Primary: Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 — 23.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atrasentan (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- AbbVie
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 |
23.5 | — |
| 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 |
11.8 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration |
2.2; -10.6; 35.8; -16.5; -27.5; -25.8 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility |
-5.8; -7.4; -0.3; -6.3; 10.8; 1.8 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology |
-1.1; -2.2; -0.8; -6.8; -2.3; 1.8 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume |
0.0; -0.3; 0.0; 0.0; 0.1; -0.4 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone |
0.2; 0.8; 0.6; -0.3; -1.6; -1.1 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol |
-11.7; -18.6; -17.8; -47.3; 20.3; 10.5 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) |
1.0; 0.7; 1.3; 1.9; 0.5; 1.8 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) |
1.1; 0.8; 0.4; 0.7; 0.4; 0.8 | — |
| SECONDARY Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B |
-2.7; -8.8; -7.2; -22.7; -21.0; -5.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02118714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.