Trial Outcomes & Findings for Role of Everolimus in Highly Sensitized Patients (NCT NCT01911546)

NCT ID: NCT01911546

Last Updated: 2017-12-07

Results Overview

Patients will be monitored at regular interval for the development of Polyomavirus Viremia.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-12-07

Participant Flow

Highly HLA Sensitized Patients with End Stage Renal Disease Receiving Deceased Donor or Living Donor kidney transplant were enrolled.

Participant milestones

Measure	Everolimus + Low-dose Tacrolimus 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Overall Study STARTED	20
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Everolimus + Low-dose Tacrolimus 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Overall Study Lost to Follow-up	1
Overall Study Everolimus was discontinued	5

Baseline Characteristics

Role of Everolimus in Highly Sensitized Patients

Baseline characteristics by cohort

Measure	Everolimus + Low-dose Tacrolimus n=20 patients Patients receiving everolimus will be on low dose tacrolimus. everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	48.65 years STANDARD_DEVIATION 11.98 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Cause of ESRD Alport Syndrome	1 Participants n=5 Participants
Cause of ESRD Congenital	3 Participants n=5 Participants
Cause of ESRD FSGS	2 Participants n=5 Participants
Cause of ESRD HTN	3 Participants n=5 Participants
Cause of ESRD Lupus	3 Participants n=5 Participants
Cause of ESRD PCKD	2 Participants n=5 Participants
Cause of ESRD Post-Infectious Glomerulonephropathy	1 Participants n=5 Participants
Cause of ESRD Unknown Etiology	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Patients will be monitored at regular interval for the development of Polyomavirus Viremia.

Outcome measures

Measure	Everolimus + Low-dose Tacrolimus n=20 Participants 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
The Number of Polyoma BK Viremia Patients	5 Participants

PRIMARY outcome

Timeframe: 12 Months

The number of patients with CMV viremia

Outcome measures

Measure	Everolimus + Low-dose Tacrolimus n=20 Participants 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
The Number of CMV Viremia	0 Participants

PRIMARY outcome

Timeframe: 6 months

Protocol biopsies were obtained at T0 and 6 months post transplant.

Outcome measures

Measure	Everolimus + Low-dose Tacrolimus n=12 Participants 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Incidence of Antibody Mediated Rejection (ABMR)	2 Participants

SECONDARY outcome

Timeframe: 6 months

Patients will be monitored for any episodes of CMR.

Outcome measures

Measure	Everolimus + Low-dose Tacrolimus n=12 Participants 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Incidence of Cell Mediated Rejection (CMR)	2 Participants

Adverse Events

Everolimus + Low-dose Tacrolimus

Serious events: 9 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Everolimus + Low-dose Tacrolimus n=20 participants at risk 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Renal and urinary disorders Edema	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Renal and urinary disorders Urine Leak	10.0% 2/20 • Number of events 2 • From transplant to 12 months post transplant.
Renal and urinary disorders Antibody Mediated Rejection and Thrombotic Microangiopathy	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Renal and urinary disorders Antibody Mediated Rejection / FSGS /Small Bowel Obstruction/Dehydration	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Gastrointestinal disorders Inguinal Hernia	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Cardiac disorders Shortness of Breath and Atrial Fibrillation	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Renal and urinary disorders UTI	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Infections and infestations Nocardia Pneumonia	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.

Other adverse events

Measure	Everolimus + Low-dose Tacrolimus n=20 participants at risk 20 patients received everolimus with low dose tacrolimus. Everolimus + low-dose tacrolimus: Patients are supplied everolimus (Zortress) + prograf
Nervous system disorders Headache	25.0% 5/20 • Number of events 5 • From transplant to 12 months post transplant.
General disorders Weakness	10.0% 2/20 • Number of events 2 • From transplant to 12 months post transplant.
Metabolism and nutrition disorders Weight gain	5.0% 1/20 • Number of events 1 • From transplant to 12 months post transplant.
Blood and lymphatic system disorders Leukopenia	15.0% 3/20 • Number of events 3 • From transplant to 12 months post transplant.
Skin and subcutaneous tissue disorders Alopecia	10.0% 2/20 • Number of events 2 • From transplant to 12 months post transplant.
Blood and lymphatic system disorders Anemia	20.0% 4/20 • Number of events 4 • From transplant to 12 months post transplant.
Nervous system disorders General pain	40.0% 8/20 • Number of events 8 • From transplant to 12 months post transplant.

Additional Information

Dr. Joseph Kahwaji, MD, MPH

Former: Cedars-Sinai Medical Center, Comprehensive Transplant Center

Phone: 310-423-2641

Email: joseph.m.kahwaji@kp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place