Diabetes, Nephropathy
Conditions
Keywords
Diabetic Nephropathies, Kidney Diseases, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
Brief 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).
Interventions
DRUGAtrasentan
Atrasentan
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | Up to 26 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | 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. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52 | 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). |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | 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. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 | 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. |
| 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 | Up to 52 weeks after the Treatment 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. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52 | Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | From Week 0 to Treatment Week 26 and Observation Week 52 | 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. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B. |
| Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | From Week 0 up to Treatment Period Week 26 and Observation Period Week 52 | Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone. |
Countries
Germany, Italy, Spain, United States
Participant flow
Pre-assignment details
The Safety Analysis Set included all enrolled participants who received \>= 1 dose of Atrasentan (N = 20); of these 20, 6 participants entered an Observational Period of up to an additional 52 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Atrasentan Atrasentan 0.75 mg administered orally once daily (QD). | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Atrasentan |
|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 12.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 12 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
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.
Time frame: Up to 26 weeks
Population: Evaluable Set: Subjects who met 1 of the following: Study drug compliance ≥ 70%, completed Treatment Period, all planned sperm samples collected; or 2) at least 1 dose study drug, a sperm concentration value that was \<15 million/mL observed by the end of the Treatment Period or had a ≥50% reduction from Baseline at the end of the Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atrasentan | Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 | 23.5 percentage of participants |
80% CI: [10.7, 41.6]
95% CI: [6.8, 49.9]
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.
Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Treatment Period Week 13 | -11.7 Picomoles Per Litre (pmol/L) | Standard Deviation 44.57 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Treatment Period Week 26 | -18.6 Picomoles Per Litre (pmol/L) | Standard Deviation 42.04 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Observation Period Week 13 | -17.8 Picomoles Per Litre (pmol/L) | Standard Deviation 62.78 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Observation Period Week 26 | -47.3 Picomoles Per Litre (pmol/L) | Standard Deviation 39.97 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Observation Period Week 39 | 20.3 Picomoles Per Litre (pmol/L) | Standard Deviation 4.78 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol | Observation Period Week 52 | 10.5 Picomoles Per Litre (pmol/L) | Standard Deviation 45.54 |
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.
Time frame: From Week 0 to Treatment Week 26 and Observation Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Treatment Period Week 13 | 1.1 International Units/Liter (IU/L) | Standard Deviation 2.43 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Treatment Period Week 26 | 0.8 International Units/Liter (IU/L) | Standard Deviation 1.91 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Observation Period Week 13 | 0.4 International Units/Liter (IU/L) | Standard Deviation 1.6 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Observation Period Week 26 | 0.7 International Units/Liter (IU/L) | Standard Deviation 1.49 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Observation Period Week 39 | 0.4 International Units/Liter (IU/L) | Standard Deviation 1.57 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH) | Observation Period Week 52 | 0.8 International Units/Liter (IU/L) | Standard Deviation 0.59 |
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.
Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Treatment Period Week 13 | -2.7 picogram per milliliter (pg/mL) | Standard Deviation 24.19 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Observation Period Week 13 | -7.2 picogram per milliliter (pg/mL) | Standard Deviation 20.77 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Observation Period Week 26 | -22.7 picogram per milliliter (pg/mL) | Standard Deviation 27.1 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Observation Period Week 39 | -21.0 picogram per milliliter (pg/mL) | Standard Deviation 16.97 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Observation Period Week 52 | -5.5 picogram per milliliter (pg/mL) | Standard Deviation 2.12 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B | Treatment Period Week 26 | -8.8 picogram per milliliter (pg/mL) | Standard Deviation 34.73 |
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.
Time frame: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Treatment Period Week 13 | 1.0 International Units/Liter (IU/L) | Standard Deviation 2.6 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Treatment Period Week 26 | 0.7 International Units/Liter (IU/L) | Standard Deviation 2.44 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Observation Period Week 13 | 1.3 International Units/Liter (IU/L) | Standard Deviation 1.33 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Observation Period Week 26 | 1.9 International Units/Liter (IU/L) | Standard Deviation 2.35 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Observation Period Week 39 | 0.5 International Units/Liter (IU/L) | Standard Deviation 0.07 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH) | Observation Period Week 52 | 1.8 International Units/Liter (IU/L) | Standard Deviation 3.46 |
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.
Time frame: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Treatment Period Week 13 | 0.0 milliliter (mL) | Standard Deviation 0.65 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Treatment Period Week 26 | -0.3 milliliter (mL) | Standard Deviation 0.75 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Observation Period Week 13 | 0.0 milliliter (mL) | Standard Deviation 1.39 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Observation Period Week 26 | 0.0 milliliter (mL) | Standard Deviation 0.35 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Observation Period Week 39 | 0.1 milliliter (mL) | Standard Deviation 0.42 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume | Observation Period Week 52 | -0.4 milliliter (mL) | Standard Deviation 0.14 |
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.
Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Treatment Period Week 13 | 0.2 nanomole/liter (nmol/L) | Standard Deviation 2.18 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Treatment Period Week 26 | 0.8 nanomole/liter (nmol/L) | Standard Deviation 2.33 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Observation Period Week 13 | 0.6 nanomole/liter (nmol/L) | Standard Deviation 2.08 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Observation Period Week 26 | -0.3 nanomole/liter (nmol/L) | Standard Deviation 0.85 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Observation Period Week 39 | -1.6 nanomole/liter (nmol/L) | Standard Deviation 1.37 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone | Observation Period Week 52 | -1.1 nanomole/liter (nmol/L) | Standard Deviation 1.68 |
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.
Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Treatment Period Week 13 | 2.2 sperm * million per milliliter(X10^6/mL) | Standard Deviation 42.21 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Treatment Period Week 26 | -10.6 sperm * million per milliliter(X10^6/mL) | Standard Deviation 53.44 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Observation Period Week 13 | 35.8 sperm * million per milliliter(X10^6/mL) | Standard Deviation 113.6 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Observation Period Week 26 | -16.5 sperm * million per milliliter(X10^6/mL) | Standard Deviation 0 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Observation Period Week 39 | -27.5 sperm * million per milliliter(X10^6/mL) | Standard Deviation 19.09 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration | Observation Period Week 52 | -25.8 sperm * million per milliliter(X10^6/mL) | Standard Deviation 1.06 |
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.
Time frame: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Observation Period Week 13 | -0.8 percentage of normal | Standard Deviation 7.53 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Observation Period Week 26 | -6.8 percentage of normal | Standard Deviation 0.35 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Observation Period Week 39 | -2.3 percentage of normal | Standard Deviation 1.77 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Observation Period Week 52 | 1.8 percentage of normal | Standard Deviation 0.35 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Treatment Period Week 13 | -1.1 percentage of normal | Standard Deviation 4.78 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology | Treatment Period Week 26 | -2.2 percentage of normal | Standard Deviation 7.54 |
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).
Time frame: From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
Population: All participants in the Safety Analysis Set (defined as enrolled participants who receive \>= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Treatment Period Week 13 | -5.8 percent motility | Standard Deviation 13.65 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Treatment Period Week 26 | -7.4 percent motility | Standard Deviation 15.77 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Observation Period Week 13 | -0.3 percent motility | Standard Deviation 19.2 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Observation Period Week 26 | -6.3 percent motility | Standard Deviation 5.3 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Observation Period Week 39 | 10.8 percent motility | Standard Deviation 15.2 |
| Atrasentan | Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility | Observation Period Week 52 | 1.8 percent motility | Standard Deviation 16.62 |
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.
Time frame: Up to 52 weeks after the Treatment Period
Population: Evaluable Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atrasentan | 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 percentage of participants |
80% CI: [3.2, 28.4]
95% CI: [1.5, 36.4]