--- title: Calcineurin Inhibitor-free, Steroid-free Immunosuppressive Regimen in Simultaneous Islet-Kidney Transplantation for Uremic Type 1 Diabetic Patients nct_id: NCT01033500 overall_status: WITHDRAWN phase: NA sponsor: University of Wisconsin, Madison study_type: INTERVENTIONAL primary_condition: Islets of Langerhans Transplantation countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01033500.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01033500" ct_last_update_post_date: 2013-05-08 last_seen_at: "2026-05-12T06:32:09.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Calcineurin Inhibitor-free, Steroid-free Immunosuppressive Regimen in Simultaneous Islet-Kidney Transplantation for Uremic Type 1 Diabetic Patients **NCT ID:** [NCT01033500](https://clinicaltrials.gov/study/NCT01033500) ## Key Facts - **Status:** WITHDRAWN - **Why Stopped:** Insufficient funding - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 0 - **Lead Sponsor:** University of Wisconsin, Madison - **Collaborators:** Bristol-Myers Squibb - **Conditions:** Islets of Langerhans Transplantation, Diabetes Mellitus, Type 1, Kidney Transplantation - **Start Date:** 2010-07 - **Completion Date:** 2012-12 - **CT.gov Last Update:** 2013-05-08 ## Brief Summary The investigators hypothesize that a calcineurin inhibitor-free, steroid-free, co-stimulatory blockade-based immunosuppressive regimen, in combination with a GLP-1 agonist, will reduce the islet mass required to achieve and sustain insulin independence following simultaneous islet-kidney transplantation. ## Detailed Description This is a single center, open-label, non-randomized, prospective, pilot study of 8 Type 1 diabetic/uremic patients, ages 18-60 undergoing simultaneous islet-kidney transplantation. Study to include both male and/or female subjects. We hypothesize that a calcineurin inhibitor-free, steroid-free, co-stimulatory blockade-based immunosuppressive regimen, in combination with a GLP-1 agonist, will reduce the islet mass required to achieve and sustain insulin independence following simultaneous islet-kidney transplantation. Furthermore, we anticipate an improvement in creatinine clearance and a reduction in Interstitial Fibrosis/Tubular Atrophy in the transplanted renal allograft, and a reduction of "de novo" human anti-HLA antibody and auto-antibody formation against the respective donors. Without calcineurin inhibitors or steroids, we hypothesize that belatacept, in conjunction with sirolimus and mycophenolic acid will provide balanced immunosuppression for combined islet-kidney transplantation. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Subjects will include those with Type 1 Diabetes Mellitus, undergoing kidney transplantation, and: * are closely followed by a primary care provider and/or endocrinologist for \>6 months prior to enrollment in the trial * do not have psychogenic factors which preclude therapeutic compliance * have a fasting C-peptide of \<0.2 ng/mL• have diabetes for \>5 years • are between 18 and 65 years of age * have a creatinine clearance of less than 20 mL/min * have a body mass index of less than or equal to 28 * In the case of women of childbearing potential (WOCBP), must have a negative pregnancy test and avoid pregnancy throughout the study and 8 weeks after final dose of study drug. * WOCBP must use two adequate methods of contraception. * A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy. Exclusion Criteria: * Untreated proliferative diabetic retinopathy * HgbA1C \>12 * creatinine clearance \> 20 ml/minute * presence of panel reactive antibodies (PRA) \>20% (per CDC-based assay) * malignancy or previous malignancy, except for adequately treated skin cancers (basal cell or squamous cell carcinoma) within the past 5 years * sensitivity to iodine and/or shellfish (re: Iothalamate-based GFR testing) * x-ray evidence of pulmonary infection * active infections * active peptic ulcer disease, gall stones, hemangioma, cirrhosis or portal hypertension * serological evidence of HIV, HBSAg or HCV * abnormal liver function tests (elevated AST and ALT \> 2x upper limit of normal) * anemia (hemoglobin) \<9 gm/dl * serum triglycerides \>200 mg/dl * serum cholesterol \>240 mg/dl * body mass index above 28 * unstable cardiovascular status (including positive stress echocardiography if \>age 35); severe coexisting cardiac disease, myocardial infarction within the 6 months prior to enrollment in the study, left ventricular ejection fraction of \<30%, or evidence of ongoing ischemia * prostate specific antigen (PSA) \>4 in males \>40 years old or with family history of prostate cancer * pregnancy or breastfeeding * sexually-active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable) * alcohol abuse, substance abuse or smoking within the previous 6 months * insulin requirement \>1.5 u/kg/day * negative for Epstein-Barr virus by IgG determination * history of factor V deficiency * acute or chronic pancreatitis * recurrent attenuated vaccine(s) within the previous 2 months * use of an investigational agent within the past 4 weeks * sexually active, fertile men not using effective birth control, if their partners are WOCBP * prisoners, or subjects who are involuntarily incarcerated * subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness * Previous kidney transplant or previous non-renal transplant * kidney transplant from expanded criteria donor (ECD) * kidney cold ischemic time projected to be \> 20 hours * currently receiving immunosuppressive agents for autoimmune disease or other conditions or have comorbidities that treatment with such agents are likely during the trial * any condition or circumstance that makes it unsafe to undergo an islet cell or kidney transplant ``` ## Arms - **SIK** (EXPERIMENTAL) — Basiliximab induction with maintenance immunosuppression consisting of belatacept, sirolimus or everolimus, and mycophenolate after simultaneous islet kidney transplantation. ## Interventions - **Belatacept** (DRUG) — Belatacept 10mg/kg on Days 0, 4, 14, 28, 56, and 84 post-transplant, and then 5mg/kg every 4 weeks for the duration of the study. ## Primary Outcomes - **Achieve and consistently maintain insulin independence in simultaneous islet-kidney transplant recipients for one year.** _(time frame: 1 year)_ ## Locations (1) - University of Wisconsin, Madison, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.university of wisconsin|madison|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01033500.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01033500* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*