NCT02118714

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

April 6, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

April 14, 2014

Results QC Date

April 8, 2019

Last Update Submit

May 3, 2019

Conditions

NephropathyDiabetes

Keywords

Diabetic NephropathiesKidney DiseasesUrologic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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

    From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52

  • +5 more secondary outcomes

Study Arms (1)

Atrasentan

EXPERIMENTAL

Atrasentan 0.75 mg administered orally once daily (QD) for 26 weeks

Drug: Atrasentan

Interventions

AtrasentanDRUG

Atrasentan

Atrasentan

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Alliance Research Centers /ID# 125945

Laguna Hills, California, 92653-3621, United States

Location

Frank Clark Urology Center /ID# 147794

Santa Monica, California, 90404, United States

Location

Research by Design, LLC /ID# 160784

Evergreen Park, Illinois, 60805, United States

Location

Southern IL Univ School of Med /ID# 129010

Springfield, Illinois, 62702, United States

Location

Crescent City Clinical Res Ctr /ID# 150989

Metairie, Louisiana, 70006, United States

Location

Tulane Univ /ID# 130308

New Orleans, Louisiana, 70112, United States

Location

Albany Medical College /ID# 131068

Albany, New York, 12208, United States

Location

Urologic Consultants of Southeastern Pennsylvania /ID# 124277

Bala-Cynwyd, Pennsylvania, 19004-1017, United States

Location

Eastern Virginia Med School /ID# 153740

Norfolk, Virginia, 23507-1627, United States

Location

Charite Research Organisation GmbH /ID# 154264

Berlin, 10117, Germany

Location

Ospedale S. Carlo Borromeo /ID# 151672

Milan, 20153, Italy

Location

SCDU Nefrologia e dialisi-CMID /ID# 151673

Torino, 10154, Italy

Location

Hospital Universitario Reina S /ID# 151692

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Kidney DiseasesDiabetes MellitusDiabetic NephropathiesUrologic DiseasesDiabetes ComplicationsEndocrine System Diseases

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzodioxolesDioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolidinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 21, 2014

Study Start

April 6, 2015

Primary Completion

April 18, 2018

Study Completion

July 16, 2018

Last Updated

May 7, 2019

Results First Posted

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information

Locations

DE(1)US(9)ES(1)IT(2)