Trial Outcomes & Findings for Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant (NCT NCT03380377)

Last Updated: 2025-05-06

Results Overview

Did clazakizumab eliminate or weaken donor specific antibody (DSA) mean fluorescence intensity (MFI) intensities? HLA antibodies were detected by the single antigen bead-based assay (One lambda, Los Angeles, CA). Donor HLA-specific antibodies were assessed throughout clazakizumab treatment for the first year. Detection of DSAs were only reported with MFI \>2500.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

12 months

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Clazakizumab (Anti-IL-6 Monoclonal) All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clazakizumab (Anti-IL-6 Monoclonal) All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=10 Participants All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Age, Continuous	51 years 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
Region of Enrollment United States	10 Participants n=5 Participants
estimated Glomerular Filtration Rate (eGFR)	38.11 ml/min/1.73m2 STANDARD_DEVIATION 12.23 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=8 Participants All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing	7 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 9 of 10 patients underwent the 6 month protocol biopsy (One patient was withdrawn from study at 3 months and did not complete the 6 month biopsy)

Does clazakizumab help stabilize pathologic features of antibody mediated rejection at 6 month protocol biopsies? Protocol kidney allograft biopsies were performed at 6 months and compared to the baseline biopsy which was assessed for study inclusion. Biopsy specimens were analyzed according to Banff 2017 classification.

Outcome measures

Outcome measures
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=9 Participants All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Number of Participants With Stabilization of Clinical Features of cABMR Via BANFF Biopsy Grading Criteria.	9 Participants

SECONDARY outcome

Timeframe: 12 months

Serum creatinine (mg/dl) collected to calculate eGFR

Outcome measures

Outcome measures
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=8 Participants All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Stabilization in Estimated Glomerular Filtration Rate (eGFR)	41.6 ml/min/1.73m2 Standard Deviation 14.2

SECONDARY outcome

Timeframe: 12 months

Adverse event monitoring in our patient population; did patients have treatment related adverse events and if so, how many events

Outcome measures

Outcome measures
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=8 Participants All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Incidence of Treatment-related Adverse Events	0 Participants

Adverse Events

Clazakizumab (Anti-IL-6 Monoclonal)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=10 participants at risk All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Renal and urinary disorders Sepsis due to pyelonephritis	20.0% 2/10 • Number of events 2 • 1 year

Other adverse events

Other adverse events
Measure	Clazakizumab (Anti-IL-6 Monoclonal) n=10 participants at risk All ten patients will be receiving clazakizumab (Anti-IL-6 Monoclonal) monthly for six months. Then patients will be scheduled for six month protocol biopsy. If biopsy and all clinical labs show benefit or stability (up to PI discretion), patients will continue receiving clazakizumab monthly for another six months. All patients completing twelve doses of clazakizumab will be scheduled for a twelve month protocol biopsy and last study visit. If at the 6 month protocol biopsy, no improvement was seen, PI will have patient come for their last study visit on month 12 post enrollment. Clazakizumab: Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
Infections and infestations EBV Viremia	10.0% 1/10 • Number of events 1 • 1 year
Infections and infestations Herpes Zoster	20.0% 2/10 • Number of events 2 • 1 year
Renal and urinary disorders Pyelonephritis	30.0% 3/10 • Number of events 4 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Tract Infection	30.0% 3/10 • Number of events 3 • 1 year
Infections and infestations C difficile infection	10.0% 1/10 • Number of events 1 • 1 year
Infections and infestations Influenza	10.0% 1/10 • Number of events 1 • 1 year
Infections and infestations Cough and/or Cold	20.0% 2/10 • Number of events 2 • 1 year
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1 • 1 year
General disorders Fever	10.0% 1/10 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Arm swelling/cellulitis	20.0% 2/10 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders Eczema/warts on hands	10.0% 1/10 • Number of events 1 • 1 year
General disorders Intermittent dizziness	10.0% 1/10 • Number of events 1 • 1 year
General disorders Edema	30.0% 3/10 • Number of events 5 • 1 year
Skin and subcutaneous tissue disorders Itching on legs	10.0% 1/10 • Number of events 1 • 1 year
General disorders Swollen hand after exercise	10.0% 1/10 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Uric acid elevated/gout in big toe	10.0% 1/10 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Excision of skin cancer lesion	20.0% 2/10 • Number of events 2 • 1 year
Blood and lymphatic system disorders Anemia	20.0% 2/10 • Number of events 3 • 1 year
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Number of events 1 • 1 year
Reproductive system and breast disorders Vaginitis	10.0% 1/10 • Number of events 1 • 1 year

Additional Information

Stan Jordan, MD

Cedars Sinai Medical Center

Phone: 3104232641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place