Kidney TransplantationPhase 2CAMPBELNCT03591380
CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients
A Phase 2 study testing Belimumab in people with Kidney Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Belimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2019to 3 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects 18-60 years of age
- Planned to receive a deceased or living donor kidney transplant
- Sensitized patients: Positive sum DSA <1000, and/or PRA>0%.
- Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
- Female subjects must be post-menopausal, surgically sterilized, or she and/or sexual partner must be willing to use an acceptable method of birth control with a <1% failure rate as stated in the product label from time of study consent, during study participation, and for 16 weeks after the last dose of the study agent (i.e., contraceptive subdermal implant of levonorgestrel or etonogestrel, intrauterine device or intrauterine system, combined estrogen and progestogen oral contraceptive, Injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches, or abstinence) for the duration of the study. Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation of male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner. Note: Mycophenolate mofetil (MMF) affects the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g., barrier method). Mycophenolate can cause fetal harm when administered to a pregnant female. Use of mycophenolate during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Mycophenolate affects the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g., barrier method) resulting in two reliable forms of contraception being used simultaneously before starting study treatments, during therapy, and for 6 weeks after stopping therapy; unless abstinence is the chosen method of contraception
- Female patients of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant. Must be willing to use contraceptives from the time of study consent, during study participation, and for 16 weeks after the last dose of study agent. For sexually active men, condoms should be used during, and for at least 90 days after cessation of mycophenolate treatment. No sperm donation should be made during this period of time. For female partners of male subjects, it is recommended to use highly effective contraception during treatment and for 90 days after the last dose of mycophenolate
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- No blood donation should be made by the study subjects during mycophenolate treatment and for at least 6 weeks after stopping mycophenolate treatment
- If stricter female or male contraception requirements are specified in the country-specific label for any study related therapies, they must be followed.
- Male subjects must agree to use an acceptable method for contraception for the duration of the study.
- Female patients of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant. Must be willing to use contraceptives from the time of study consent, during study participation, and for 16 weeks after the last dose of study agent. Reproductive Status: Definition of Women of Child-Bearing Potential (WOCBP). WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below).
- Post-menopause is defined as:
- Women who have had amenorrhea for greater than or equal to 12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL.
- Women who have irregular menstrual periods and a documented serum FSH level > 35 mIU/mL.
- Women who are taking hormone replacement therapy (HRT).
- The following women are WOCBP:
- Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
- Women who are practicing abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
- Women who have a partner who is sterile (e.g., due to vasectomy). WOCBP must be using an acceptable method of contraception to avoid pregnancy from the time of consent with <1% failure rate as stated in the product label throughout study participation, and for 16 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized. Acceptable methods of contraception include: complete abstinence, any form of intra-uterine devices (without hormones), tubal sterilization or your partner has had a vasectomy.
- Other acceptable forms of birth control include choosing one hormonal and one barrier method or double-barrier methods. Barrier methods include Essure®, male or female condom, diaphragm with spermicide, shield, cap with spermicide, contraceptive sponge, and spermicidals. Hormonal methods include oral contraceptive pills, transdermal patches, vaginal rings, progesterone-only, and injections. Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.
- WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to transplant (and the first dose of study drug intraoperatively).Women must not be breast-feeding
Who cannot join
- ABO incompatible donor kidney
- Deceased donor <5 years of age
- KDPI greater than or equal to 85%
- HLA identical or matched kidney
- Transplant other than kidney: has previously received a hematopoietic stem cell/marrow transplant or an organ transplant other than a kidney (with the exception of corneal transplantation)
- T- and/or B-cell positive crossmatch by complement dependent cytotoxicity or flow cytometry against the recipient
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- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
- Hospitalization for treatment of infection within 60 days of Day 0
- Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0
- Have a history of a primary immunodeficiency
- Uncontrolled infection or any other unstable medical condition that could interfere with the study
- Seropositive for HIV, HCV or HBV, except for hepatitis B surface antibody positive
- Have a significant IgG deficiency (IgG level < 400 mg/dl) Have an IgA deficiency (IgA level < 10 mg/dL)
- Prior therapy at any time: has ever received any of the following: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 agents, anti-CD2 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI fragment, crystallizable (Fc), belimumab), or IV cyclophosphamide
- Live vaccines within 30 days
- Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
- Patients with a lymphocyte count less than 500/mm3
- Patients with evidence of current drug or alcohol abuse or dependence.
- Patients with venous access limitations likely to preclude monthly infusions
- Patients whom are unlikely to comply with scheduled study visits based on investigator judgment or has a history of substance abuse, psychiatric disorder or condition that may compromise communication with the investigator
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiography evidence of acute ischemia or active conduction system abnormalities
- Diagnosis of liver cirrhosis or chronic viral hepatitis
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Patient has received other investigational drugs within 365 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
- Diagnosed or treated for malignancy within 5 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Have any other clinically significant abnormal laboratory value in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
About this study
Official title: CAMPath and BELimumab for the Induction of Donor Specific Humoral Transplant Tolerance in Sensitized Kidney Transplant Recipients To Improve Long-Term Allograft Survival
The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantation. The presence of DSA increases the risk that the kidney transplant recipient's body will reject the new kidney. The investigators are doing this research because it is estimated that greater than 50% of kidney transplant failures are attributed to antibodies produced in the body, that attack the transplanted organ as a foreign object. DSA produced in the body after a kidney transplant, is thought to occur in 20-50% of patients and is associated with a low likelihood that the organ recipient's body will accept the new kidney. A major unmet need in the kidney transplant area are safe and effective therapies to prevent DSA after transplantation.
Read the detailed description
Accrual Objective: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
Study Design: This is an open-label pilot-study to evaluate the safety and efficacy of belimumab plus standard of care in the prevention of de novo donor specific antibody in adult subjects after kidney transplantation.
The investigators will enroll 5 adult, deceased or living donor kidney transplant recipients who are sensitized, evidenced by: Positive sum Donor Specific Antibody (DSA)<1000 MFI and/or Panel of Reactive Antibodies (PRA)>0%. The primary endpoint of this study is de novo DSA production. There are two main reasons for selecting this patient population for the proposed study. 1) Sensitized patients are known to have higher rates of de novo DSA production and 2) Patients with low levels of DSA (sum DSA<1000 MFI) will enable more fidelity in determining the DSA that is produced de novo.
Kidney transplant recipients will receive the standard of care (alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression), plus six months of therapy with belimumab. Belimumab 10 mg/kg will be administered IV for 6 months at the following intervals: Day of transplant (Day 0), and then at Weeks 2, 4, 8, 12, 16, and 20 post-transplant.
Study Duration: Subjects will be treated for 6 months with belimumab and followed for DSA production for 1 year.
Primary Study Objectives: In this proposal the investigators plan to determine (a) whether the addition of belimumab to the standard of care (SOC: alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) is safe and effective in preventing de novo DSA production at 1, 3, 6, 9, and 12 months post-transplant.
Secondary efficacy endpoints will be 1) graft survival and function as determined by serum creatinine/eGFR and urine protein at 1, 3, 6, 9, and 12 months 2) rates of acute cellular and antibody mediated rejection, at 1, 3, 6, 9, and 12 months.
Primary Outcomes: To determine whether the addition of belimumab to the standard of care (SOC: alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) is safe and effective in preventing de novo DSA production 1, 3, 6, 9, and 12 months.
Secondary Outcomes: Secondary endpoints will be 1) graft survival and function as determined by serum creatinine/eGFR and urine protein at 1, 3, 6, 9, and 12 months 2) rates of acute cellular and antibody mediated rejection at 1, 3, 6, 9, and 12 months and 3) the nature, frequency, and severity of serious and non-serious adverse events ≥Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
- Conditions
- Kidney Transplantation
- Being tested
- Belimumab
- Keywords
- Donor Specific Antibody, Donors, Living, Allograft Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelimumabDrug
Also called Benlysta
Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Belimumab | Experimental | Belimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks. Receives: Drug: Belimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Are DSA Positive as Measured by Mean Fluorescence Intensity Greater Than Zero for DSA
Use descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function as determined by serum creatinine/eGFR and urine protein, rates of acute cellular and antibody mediated rejection.
Measured: 12 months from the time of transplant.
Secondary outcomes (5)
Number of Participants With DSA Development, Graft Survival, and Cellular and Antibody Rejection
Use descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function, and rates of acute cellular and antibody mediated rejection
Measured: 12 months from the time of transplant
Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Use descriptive statistics to report the nature, frequency, and severity of serious and non-serious adverse events greater than or equal to Grade 2.
Measured: Monitored for 12 months from the time of transplant
Graft Survival and Function by Serum Creatinine
Use descriptive statistics to describe the rate of graft survival and function as determined by serum creatinine
Measured: 1, 3, 6, 9, and 12 months from the time of transplant
Graft Survival and Function by eGFR
Use descriptive statistics to describe the rate of graft survival and function as determined by eGFR.
Measured: 1, 3, 6, 9, and 12 months from the time of transplant
Graft Survival and Function by Urine Protein
Use descriptive statistics to describe the rate of graft survival and function as determined by urine protein.
Measured: 1, 3, 6, 9, and 12 months from the time of transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start14 May 2019
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Why it stopped: Recruitment complications due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is proposed to be an open-label, single-arm, pilot study to test whether the addition of belimumab, to inhibit the B cell survival factor BLyS at the time of kidney transplantation, to standard or care therapy (alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) will prevent the prevent the generation of de novo DSA
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, American College of Surgeons
- Responsible party
- Sponsor
- Investigators
- David Foley, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591380
- Sponsor's protocol ID
- 2017-1385
- Other IDs
- Protocol Version 8/17/2020, A539742, SMPH/SURGERY/TRANSPLANT
- Acronym
- CAMPBEL
- Status last verified
- Dec 2022
- First submitted
- 3 May 2018
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMPath and BELimumab for the Induction of Donor Specific Humoral Transplant Tolerance in Sensitized Kidney Transplant Recipients To Improve Long-Term Allograft Survival
- ClinicalTrials.gov ID
- NCT03591380
- Acronym / sponsor ID
- CAMPBEL / 2017-1385
- Conditions
- Kidney Transplantation
- Keywords
- Donor Specific Antibody, Donors, Living, Allograft Tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment complications due to COVID-19
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, American College of Surgeons
- Study start
- 14 May 2019 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether kidney transplant recipients who receive belimumab (Benlysta®), combined with the standard of care medications for kidney transplant recipients, is safe and effective in helping prevent new donor specific antibodies (DSA) after transplantation. The presence of DSA increases the risk that the kidney transplant recipient's body will reject the new kidney. The investigators are doing this research because it is estimated that greater than 50% of kidney transplant failures are attributed to antibodies produced in the body, that attack the transplanted organ as a foreign object. DSA produced in the body after a kidney transplant, is thought to occur in 20-50% of patients and is associated with a low likelihood that the organ recipient's body will accept the new kidney. A major unmet need in the kidney transplant area are safe and effective therapies to prevent DSA after transplantation.
Detailed description
Accrual Objective: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
Study Design: This is an open-label pilot-study to evaluate the safety and efficacy of belimumab plus standard of care in the prevention of de novo donor specific antibody in adult subjects after kidney transplantation.
The investigators will enroll 5 adult, deceased or living donor kidney transplant recipients who are sensitized, evidenced by: Positive sum Donor Specific Antibody (DSA)<1000 MFI and/or Panel of Reactive Antibodies (PRA)>0%. The primary endpoint of this study is de novo DSA production. There are two main reasons for selecting this patient population for the proposed study. 1) Sensitized patients are known to have higher rates of de novo DSA production and 2) Patients with low levels of DSA (sum DSA<1000 MFI) will enable more fidelity in determining the DSA that is produced de novo.
Kidney transplant recipients will receive the standard of care (alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression), plus six months of therapy with belimumab. Belimumab 10 mg/kg will be administered IV for 6 months at the following intervals: Day of transplant (Day 0), and then at Weeks 2, 4, 8, 12, 16, and 20 post-transplant.
Study Duration: Subjects will be treated for 6 months with belimumab and followed for DSA production for 1 year.
Primary Study Objectives: In this proposal the investigators plan to determine (a) whether the addition of belimumab to the standard of care (SOC: alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) is safe and effective in preventing de novo DSA production at 1, 3, 6, 9, and 12 months post-transplant.
Secondary efficacy endpoints will be 1) graft survival and function as determined by serum creatinine/eGFR and urine protein at 1, 3, 6, 9, and 12 months 2) rates of acute cellular and antibody mediated rejection, at 1, 3, 6, 9, and 12 months.
Primary Outcomes: To determine whether the addition of belimumab to the standard of care (SOC: alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) is safe and effective in preventing de novo DSA production 1, 3, 6, 9, and 12 months.
Secondary Outcomes: Secondary endpoints will be 1) graft survival and function as determined by serum creatinine/eGFR and urine protein at 1, 3, 6, 9, and 12 months 2) rates of acute cellular and antibody mediated rejection at 1, 3, 6, 9, and 12 months and 3) the nature, frequency, and severity of serious and non-serious adverse events ≥Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is proposed to be an open-label, single-arm, pilot study to test whether the addition of belimumab, to inhibit the B cell survival factor BLyS at the time of kidney transplantation, to standard or care therapy (alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) will prevent the prevent the generation of de novo DSA
| Arm | Type | Receives |
|---|---|---|
| Experimental: Belimumab | Experimental | Drug: BelimumabBelimumab 10mg/kg will be administered IV at the following intervals: at the time of transplant (Day 0), then post-transplant at 2, 4, 8, 12, 16, and 20 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Male or female subjects 18-60 years of age
- Planned to receive a deceased or living donor kidney transplant
- Sensitized patients: Positive sum DSA <1000, and/or PRA>0%.
- Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
- Female subjects must be post-menopausal, surgically sterilized, or she and/or sexual partner must be willing to use an acceptable method of birth control with a <1% failure rate as stated in the product label from time of study consent, during study participation, and for 16 weeks after the last dose of the study agent (i.e., contraceptive subdermal implant of levonorgestrel or etonogestrel, intrauterine device or intrauterine system, combined estrogen and progestogen oral contraceptive, Injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches, or abstinence) for the duration of the study. Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation of male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner. Note: Mycophenolate mofetil (MMF) affects the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g., barrier method). Mycophenolate can cause fetal harm when administered to a pregnant female. Use of mycophenolate during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Mycophenolate affects the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g., barrier method) resulting in two reliable forms of contraception being used simultaneously before starting study treatments, during therapy, and for 6 weeks after stopping therapy; unless abstinence is the chosen method of contraception
Key exclusion criteria (28 listed)
- ABO incompatible donor kidney
- Deceased donor <5 years of age
- KDPI greater than or equal to 85%
- HLA identical or matched kidney
- Transplant other than kidney: has previously received a hematopoietic stem cell/marrow transplant or an organ transplant other than a kidney (with the exception of corneal transplantation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelimumabAlso: BenlystaKidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab. | Drug | Experimental: Belimumab |
Primary outcome
Number of Participants That Are DSA Positive as Measured by Mean Fluorescence Intensity Greater Than Zero for DSA
Time frame: 12 months from the time of transplant.
Use descriptive statistics to describe the rate of de novo DSA development as determined using Luminex, graft survival and function as determined by serum creatinine/eGFR and urine protein, rates of acute cellular and antibody mediated rejection.
5 secondary outcomes
Number of Participants With DSA Development, Graft Survival, and Cellular and Antibody Rejection
Time frame: 12 months from the time of transplant
Report the Nature, Frequency, and Severity of Serious and Non-serious Adverse Events Greater Than or Equal to Grade 2 Per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Time frame: Monitored for 12 months from the time of transplant
Graft Survival and Function by Serum Creatinine
Time frame: 1, 3, 6, 9, and 12 months from the time of transplant
Graft Survival and Function by eGFR
Time frame: 1, 3, 6, 9, and 12 months from the time of transplant
Graft Survival and Function by Urine Protein
Time frame: 1, 3, 6, 9, and 12 months from the time of transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Foley, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belimumab in people with Kidney Transplantation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Are DSA Positive as Measured by Mean Fluorescence Intensity Greater Than Zero for DSA (time frame: 12 months from the time of transplant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.