NephropathyPhase 2NCT02118714

Atrasentan Spermatogenesis and Testicular Function

A Phase 2 study testing Atrasentan in people with Nephropathy and Diabetes, run by AbbVie at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 30 to 75 years, men only
Conditions the study is for: Nephropathy, Diabetes
What is being tested?: Atrasentan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 13 sitesin 4 countries
Study dates: 6 Apr 2015to 16 Jul 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

United States9 sites

Albany Medical College /ID# 131068
Albany, New York, 12208
Urologic Consultants of Southeastern Pennsylvania /ID# 124277
Bala-Cynwyd, Pennsylvania, 19004-1017
Research by Design, LLC /ID# 160784
Evergreen Park, Illinois, 60805
Alliance Research Centers /ID# 125945
Laguna Hills, California, 92653-3621
Crescent City Clinical Res Ctr /ID# 150989
Metairie, Louisiana, 70006
Tulane Univ /ID# 130308
New Orleans, Louisiana, 70112
Eastern Virginia Med School /ID# 153740
Norfolk, Virginia, 23507-1627
Frank Clark Urology Center /ID# 147794
Santa Monica, California, 90404
Southern IL Univ School of Med /ID# 129010
Springfield, Illinois, 62702

Other trials in United States

Italy2 sites

Ospedale S. Carlo Borromeo /ID# 151672
Milan, 20153
SCDU Nefrologia e dialisi-CMID /ID# 151673
Torino, 10154

Other trials in Italy

Germany1 site

Charite Research Organisation GmbH /ID# 154264
Berlin, 10117

Other trials in Germany

Spain1 site

Hospital Universitario Reina S /ID# 151692
Córdoba, 14004

Other trials in Spain

About this study

Official title: A Multicenter, Single-Arm Study of the Effects of Atrasentan on 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).

Conditions: Nephropathy, Diabetes
Being tested: Atrasentan
Keywords: Diabetic Nephropathies, Kidney Diseases, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
Medical subject headings: Kidney Diseases, Diabetes Mellitus, Diabetic Nephropathies, Urologic Diseases, Diabetes Complications, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtrasentanDrug
Atrasentan

Study groups in NCT02118714
Study group	Role	What they receive
Atrasentan	Experimental	Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks Receives: Drug: Atrasentan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 26 weeks

Secondary outcomes (10)

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.
Measured: Up to 52 weeks after the Treatment Period
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.
Measured: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
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).
Measured: From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
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.
Measured: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
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.
Measured: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
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.
Measured: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
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.
Measured: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
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.
Measured: From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52
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.
Measured: From Week 0 to Treatment Week 26 and Observation Week 52
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.
Measured: From Week 0 up to Treatment Period Week 26 and Observation Period Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 201516 Jul 2018

First posted21 Apr 2014 (estimated)
Study start6 Apr 2015
Primary completion18 Apr 2018
Study completion16 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NephropathyStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02118714
Sponsor's protocol ID: M12-919
Other IDs: 2016-000722-19, 2016
Status last verified: May 2019
First submitted: 14 Apr 2014
Last updated: 7 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7

All Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function
ClinicalTrials.gov ID: NCT02118714
Acronym / sponsor ID: M12-919
Conditions: Nephropathy, Diabetes
Keywords: Diabetic Nephropathies, Kidney Diseases, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 6 Apr 2015 (actual)
Primary completion: 18 Apr 2018 (actual)
Study completion: 16 Jul 2018 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 7 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Atrasentan	Experimental	Drug: AtrasentanAtrasentan 0.75 mg administered orally once daily (QD) for 26 weeks

Who may qualify

Ages: 30 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtrasentanAtrasentan	Drug	Atrasentan

Primary outcome

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.

10 secondary outcomes

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
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
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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 7 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atrasentan	20	17

Primary outcome: Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26

Time frame: Up to 26 weeks. Number. Unit: percentage of participants

Measure	Atrasentan n = 17
Value	23.5

Atrasentan: Percentage of Participants: 23.5 (80% CI 10.7 to 41.6)
Atrasentan: Percentage of Participants: 23.5 (95% CI 6.8 to 49.9)

Population analysed: 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.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to approximately 30 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atrasentan	3 of 20 (15%)	12 of 20 (60%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Related trials for Nephropathy

Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atrasentan in people with Nephropathy and Diabetes, run by AbbVie at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Italy, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26 (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02118714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.