A Phase 1/2 interventional study of Clazakizumab in Kidney Failure, Chronic, End-Stage Renal Disease and Transplant Glomerulopathy, sponsored by Stanley Jordan, MD. Completed at 1 site in United States. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Stanley Jordan, MD · Phase 1/2, Interventional, and Treatment
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.
This is a single center, Phase I/II, open label single-arm exploratory study. The trial will primarily examine the safety and tolerability of clazakizumab given after consented and eligible patients begin desensitization therapy to achieve HLAi renal transplantation at Cedars-Sinai Medical Center. 20 subjects (ages 15 to 75) who are highly-HLA sensitized (HS) as determined by the calculated Panel Reactive Antibody (cPRA) ≥50% and are eligible for desensitization will be evaluated. All patients will be accrued from the renal transplant program at Cedars-Sinai Medical Center. Once desensitization begins, anti-HLA antibodies will be assessed which are associated with antibody-mediated rejection (ABMR) and/or graft loss. HLA antibodies will be detected using solid phase assay systems currently utilized at the Cedars-Sinai Medical Center HLA Laboratory. These anti-HLA antibodies may result naturally or from previous pregnancy, transfusions, or prior transplants. Patients treated with clazakizumab x 6 doses for desensitization will have blood sampling for HLA antibodies, and other monitoring blood samples as well as immunologic studies as outlined. If patients receive an HLAi transplant during the study, participants will receive the standard post-transplant immunosuppressive protocol, and clazakizumab 25 mg subcutaneous (SC) Q4 weeks X 6 doses with immune monitoring as indicated.
Immune monitoring in blood samples for regulatory T-cell (Treg), T follicular helper (Tfh), Th17 and B-cell subsets as well as interleukin-6 (IL-6) and C-reactive protein (CRP) monitoring will be carried out at the Cedars-Sinai Transplant Immunology Laboratory.
Patients identified as study participants will be HS and listed for HLAi renal transplantation at Cedars-Sinai Medical Center. Cedars-Sinai is a major U.S. desensitization center and performs \~80 HLAi renal transplants per-year. \~ 100 new HS patients are referred to Cedars-Sinai each year as potential candidates for desensitization. Eligible patients entering the study will initially receive plasmapheresis (PLEX; 5-7 sessions) + intravenous immunoglobulin (IVIG) and receive clazakizumab 25 mg SC one week post-IVIG. If no safety/tolerability/efficacy issues are observed after the initial dose, patients will receive 5 additional injections Q4 weeks. If patients receive an HLAi transplant, clazakizumab will be continued for 6 months (M) post- transplant at 25mg SC Q4weeks for 6 doses (starting at Day 5 post-transplant). A protocol biopsy will be performed at 6M post-transplant to assess the allograft for evidence of ABMR, including C4d staining and TG using Banff 2015 criteria. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy. In the event a patient does not show improvement after receiving 6 doses of clazakizumab, no further treatment will be given and the patient will return at Day 365 for a final study visit. All subjects will be evaluated on an intent-to-treat basis. The subject accrual rate will be limited to no more than 1-2 subjects per month in the initial three months to assure safety to all subjects. Repeat laboratories will be performed at the completion of clazakizumab therapy to determine effect on levels and correlation with any potential events.
The subjects will be followed to determine if the use of clazakizumab for desensitization in this high risk transplant population is safe and without infectious risks. In addition, the investigators will determine the effects of clazakizumab treatment on HLA antibodies in efforts to improve access to HLAi transplants for these individuals. The investigators have previously reported acceptance criteria for HLAi kidney transplants. Renal biopsy assessments will be performed at 6M (per protocol) and 12M (for those who received 12 doses of therapy). The investigators will assess the transplanted patients to determine the number who sustain a viable and functioning kidney allograft as well. All subjects will be evaluated on an intent-to-treat basis. The subject accrual rate will be limited to no more than 1-2 subjects per month in the initial three months to assure safety to all subjects.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 20 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Stanley Jordan, MD is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All twenty patients will receive clazakizumab monthly. Patients will receive up to 6 doses pre-transplantation. If patients are transplanted during the study, they will then receive 6 doses of clazakizumab (monthly) and a 6 month protocol biopsy will be performed. Based on the biopsy results and clinical labs Principal Investigator (PI) will determine if patients should continue monthly doses for up to another 6 doses and day 330 post-transplantation. Patients who received 12 post-transplant doses of clazakizumab will then undergo a 12 month protocol biopsy.
Drug: Clazakizumab
All patients will receive clazakizumab 25 mg subcutaneous injections (monthly) for a maximum of 18 injections.
Also known as: Anti-IL-6 monoclonal
Number of Treatment Related Adverse Effects of Clazakizumab Therapy (18 Month Period)
Assessments of any side effects associated with clazakizumab administration. Adverse event (AE) data was collected while patients received clazakizumab monthly. Patients received up to 6 monthly doses pre-transplantation (6 months). If patients were transplanted during the study, they then received 12 monthly doses of clazakizumab post-transplant (12 months). Patients were therefore monitored for safety data for up to 6 months prior to and 12 months post-transplantation (18 months in total).
Time frame: 18 months (6 months pre-transplant and 12 months post-transplant)
Change in Donor Specific Antibodies (Mean Fluorescence Intensity: MFI), Class I Antibodies, Post-transplant
Assessment of human leukocyte antigen (HLA) antibodies from baseline based on luminex assessments (MFI) to 6 months post-transplant
Time frame: 6 months post-transplant
Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-transplant.
Assessment of renal function (eGFR) by collecting Serum Creatinine (md/dl) at 12 months post-transplant.
Time frame: 12 months post-transplant
Number of Antibody Mediated Rejection (ABMR) Episodes
Assessment of biopsy results to number how many episodes of ABMR occurred in transplanted patients.
Time frame: 12 months post-transplant
Change in Donor Specific Antibodies (MFI), Class II Antibodies, Post-transplant
Assessment of HLA antibodies from baseline based on luminex assessments (MFI) to 6 months post-transplant
Time frame: 6 months post-transplant
| Milestone | Clazakizumab |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Assessments of any side effects associated with clazakizumab administration. Adverse event (AE) data was collected while patients received clazakizumab monthly. Patients received up to 6 monthly doses pre-transplantation (6 months). If patients were transplanted during the study, they then received 12 monthly doses of clazakizumab post-transplant (12 months). Patients were therefore monitored for safety data for up to 6 months prior to and 12 months post-transplantation (18 months in total).
| adverse events related to treatment | Clazakizumab |
|---|---|
| Number of Treatment Related Adverse Effects of Clazakizumab Therapy (18 Month Period) | 0 |
Assessment of human leukocyte antigen (HLA) antibodies from baseline based on luminex assessments (MFI) to 6 months post-transplant
| MFI | Clazakizumab |
|---|---|
| Change in Donor Specific Antibodies (Mean Fluorescence Intensity: MFI), Class I Antibodies, Post-transplant | 7416 ± 5369 |
Assessment of renal function (eGFR) by collecting Serum Creatinine (md/dl) at 12 months post-transplant.
| ml/min/1.73m^2 | Clazakizumab |
|---|---|
| Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-transplant. | 58 ± 29 |
Assessment of biopsy results to number how many episodes of ABMR occurred in transplanted patients.
| rejection episodes | Clazakizumab |
|---|---|
| Number of Antibody Mediated Rejection (ABMR) Episodes | 3 |
Assessment of HLA antibodies from baseline based on luminex assessments (MFI) to 6 months post-transplant
| MFI | Clazakizumab |
|---|---|
| Change in Donor Specific Antibodies (MFI), Class II Antibodies, Post-transplant | 9203 ± 5237 |
Collected over Adverse event (AE) data was collected while patients received clazakizumab monthly. Patients received up to 6 monthly doses pre-transplantation (6 months). If patients were transplanted during the study, they then received 12 monthly doses of clazakizumab post-transplant (12 months). Patients were therefore monitored for safety data for up to 6 months prior to and 12 months post-transplantation (18 months in total).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clazakizumab | 0/20 (0%) | 8/20 (40%) | 9/20 (45%) |
| Event | Clazakizumab |
|---|---|
| Urinary Tract InfectionRenal and urinary disorders | 4/20 |
| Elevated creatinineRenal and urinary disorders | 3/20 |
| BacteremiaInfections and infestations | 1/20 |
| Abdominal painGastrointestinal disorders | 1/20 |
| Perinephric fluid collection with bacteremia and UTIRenal and urinary disorders | 1/20 |
| Graft failure due to renal vein thrombosisRenal and urinary disorders | 1/20 |
| Transplant nephrectomyRenal and urinary disorders | 1/20 |
| Perinephric abscessRenal and urinary disorders | 1/20 |
| HematuriaRenal and urinary disorders | 1/20 |
| Covid-19Infections and infestations | 1/20 |
| Event | Clazakizumab |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 4/20 |
| EdemaRenal and urinary disorders | 3/20 |
| Surgical site incision painSurgical and medical procedures | 3/20 |
| AnemiaBlood and lymphatic system disorders | 3/20 |
| Itching/rashSkin and subcutaneous tissue disorders | 3/20 |
| COVID-19Infections and infestations | 2/20 |
| Elevated creatinineRenal and urinary disorders | 2/20 |
| DiarrheaGastrointestinal disorders | 2/20 |
| HyperkalemiaMetabolism and nutrition disorders | 2/20 |
| Right wrist painMusculoskeletal and connective tissue disorders | 1/20 |
| Age, Continuous(years) | Clazakizumab |
|---|---|
| Mean | 44.15 ± 11.5 |
| Sex: Female, Male(Participants) | Clazakizumab |
|---|---|
| Female | 9 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | Clazakizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Clazakizumab |
|---|---|
| United States | 20 |
| Baseline Mean Fluorescence Intensity (MFI), Class I antibodies, pre-transplant(MFI) | Clazakizumab |
|---|---|
| Mean | 12372 ± 3721 |
| Baseline Mean Fluorescence Intensity (MFI), Class II antibodies, pre-transplant(MFI) | Clazakizumab |
|---|---|
| Mean | 13526 ± 3689 |
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clazakizumab
Stanley Jordan, MD