Trial Outcomes & Findings for Ixazomib for Desensitization (NCT NCT03213158)

NCT ID: NCT03213158

Last Updated: 2022-06-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: up to 12 months
• Results posted on: 2022-06-01

Participant Flow

Participant milestones

Measure	Highly Sensitized Kidney Transplant Candidates The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Highly Sensitized Kidney Transplant Candidates The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2

Baseline Characteristics

Ixazomib for Desensitization

Baseline characteristics by cohort

Measure	Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Age, Continuous	40.8 years n=5 Participants
Age, Customized 20-29 years	2 Participants n=5 Participants
Age, Customized 30-39 years	4 Participants n=5 Participants
Age, Customized 40-49 years	2 Participants n=5 Participants
Age, Customized 50-59 years	1 Participants n=5 Participants
Age, Customized 60-69 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
cPRA 81-85%	1 Participants n=5 Participants
cPRA 86-90%	2 Participants n=5 Participants
cPRA 91-95%	0 Participants n=5 Participants
cPRA 96-100%	7 Participants n=5 Participants
Cause of ESRD Congenital	3 Participants n=5 Participants
Cause of ESRD Diabetes Mellitus (DM)	2 Participants n=5 Participants
Cause of ESRD Glomerulonephritis (GN)	1 Participants n=5 Participants
Cause of ESRD Alport's Syndrome	1 Participants n=5 Participants
Cause of ESRD Polycystic Kidney Disease (PKD)	1 Participants n=5 Participants
Cause of ESRD Systemic Lupus Erythematosus (SLE)	1 Participants n=5 Participants
Cause of ESRD Focal segmental glomerulosclerosis (FSGS)	1 Participants n=5 Participants
Previous Treatment Previous kidney transplant	7 Participants n=5 Participants
Previous Treatment 2 previous kidney transplants	2 Participants n=5 Participants
Previous Treatment Previous kidney and pancreas transplant	1 Participants n=5 Participants
Interval of Previous Treatment	11.1 years n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Efficacy of Ixazomib: Percentage of Participants With > 20 Percent Decline in Calculated Panel Reactive Antibody (cPRA)

0 Participants

PRIMARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Efficacy of Ixazomib: Percentage of Participants Received Successful Kidney Transplantation Within 12 Months

2 Participants

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib as Assesses by Percentage of Participants With Cardiovascular Complications Within 12 Months

2 Participants

SECONDARY outcome

Timeframe: up to 12 months

Hematological complications include leucopenia, anemia, and thrombocytopenia

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib as Assesses by Percentage of Participants With Hematological Complications Within 12 Months

2 Participants

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib as Assesses by Percentage of Participants With Malignancies Within 12 Months

0 Participants

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib as Assesses by Percentage of Participants With Gastrointestinal Symptoms Within 12 Months

5 Participants

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib as Assesses by Percentage of Participants Caught Infection Within 12 Months

5 Participants

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib as Assesses by Percentage of Participants With Thrombocytopenia Within 12 Months

0 Participants

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Measure

Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.

Safety of Ixazomib: as Assesses by Percentage of Participants With Distal Neuropathy Within 12 Months

1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months

B cell activating factor belonging to the TNF family (BAFF) are members of the TNF ligand superfamily. Plasma BAFF ELISA assays can be performed in 2-3 hours. It can be used as a marker of disease activity in sensitized patients.

Outcome measures

Measure	Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Change in Circulating BAFF Levels as Assessed by BAFF ELISA Assay Baseline	126 pg/ml Interval 113.0 to 146.0
Change in Circulating BAFF Levels as Assessed by BAFF ELISA Assay 3 months	160 pg/ml Interval 155.0 to 240.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months

B cell activating factor belonging to a proliferation-inducing ligand (APRIL) are members of the TNF ligand superfamily. Plasma APRIL ELISA assay can be performed in 2-3 hours. It can be used as a marker of disease activity in sensitized patients.

Outcome measures

Measure	Highly Sensitized Kidney Transplant Candidates n=10 Participants The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Change in Circulating APRIL Levels as Assessed by APRIL ELISA Assay Baseline	163 pg/ml Interval 134.0 to 198.0
Change in Circulating APRIL Levels as Assessed by APRIL ELISA Assay 3 months	172 pg/ml Interval 151.0 to 219.0

Adverse Events

Highly Sensitized Kidney Transplant Candidates

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Highly Sensitized Kidney Transplant Candidates n=10 participants at risk The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Cardiac disorders Aortic valve disease	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Bacteremia	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Hepatic infection	10.0% 1/10 • Number of events 1 • up to 12 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.0% 1/10 • Number of events 1 • up to 12 months
Vascular disorders Hematoma	20.0% 2/10 • Number of events 4 • up to 12 months
Vascular disorders Thromboembolic event	10.0% 1/10 • Number of events 2 • up to 12 months

Other adverse events

Measure	Highly Sensitized Kidney Transplant Candidates n=10 participants at risk The study population will include all highly sensitized kidney transplant candidates on the waitlist for more than 24 months at University of Wisconsin. Ixazomib Oral Capsule: Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
Infections and infestations Bacteremia	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Eye infection	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Gum infection	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Hepatic infection	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Shingles	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Thrush	10.0% 1/10 • Number of events 1 • up to 12 months
Infections and infestations Upper respiratory infection	10.0% 1/10 • Number of events 1 • up to 12 months
Gastrointestinal disorders Diarrhea	20.0% 2/10 • Number of events 4 • up to 12 months
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 4 • up to 12 months
Gastrointestinal disorders Vomiting	20.0% 2/10 • Number of events 2 • up to 12 months
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • Number of events 2 • up to 12 months
Gastrointestinal disorders Hemorrhoids	10.0% 1/10 • Number of events 1 • up to 12 months
Gastrointestinal disorders Stomach pain	10.0% 1/10 • Number of events 1 • up to 12 months
Respiratory, thoracic and mediastinal disorders Cough	20.0% 2/10 • Number of events 2 • up to 12 months
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Number of events 1 • up to 12 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	10.0% 1/10 • Number of events 1 • up to 12 months
Nervous system disorders Paresthesia	20.0% 2/10 • Number of events 9 • up to 12 months
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • up to 12 months
Cardiac disorders Cardiac disorders - Other, specify	10.0% 1/10 • Number of events 1 • up to 12 months
Cardiac disorders Chest pain - cardiac	10.0% 1/10 • Number of events 1 • up to 12 months
General disorders Edema limbs	10.0% 1/10 • Number of events 1 • up to 12 months
Investigations Investigations - Other, specify	10.0% 1/10 • Number of events 1 • up to 12 months
Metabolism and nutrition disorders Hyperglycemia	10.0% 1/10 • Number of events 6 • up to 12 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	10.0% 1/10 • Number of events 1 • up to 12 months
Psychiatric disorders Hallucinations	10.0% 1/10 • Number of events 1 • up to 12 months
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • up to 12 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	10.0% 1/10 • Number of events 1 • up to 12 months
Surgical and medical procedures Surgical and medical procedures - Other, specify	10.0% 1/10 • Number of events 1 • up to 12 months
Vascular disorders Thromboembolic event	10.0% 1/10 • Number of events 2 • up to 12 months

Additional Information

Fahid Aziz, MD

University of Wisconsin - Madison

Phone: (608) 262-5420

Email: faziz@wisc.edu

Results disclosure agreements

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