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Completed

NCT Number: NCT02118714

Atrasentan Spermatogenesis and Testicular Function

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).

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Key information

Conditions

Nephropathy Diabetes Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

30 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Charite Research Organisation GmbH /ID# 154264, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrasentan

Drug

Atrasentan

Primary outcomes

  1. Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration

    Time frame: 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.

  3. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility

    Time frame: 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).

  4. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology

    Time frame: 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.

  5. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume

    Time frame: 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.

  6. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone

    Time frame: 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.

  7. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol

    Time frame: 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.

  8. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)

    Time frame: 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.

  9. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)

    Time frame: 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.

  10. Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2014
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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