Age-Related Kidney Transplant Outcomes: Health Disparities Amplified in Adolescence

IMPORTANCE The transition from pediatric to adult health care is a vulnerable time for patients with chronic conditions. We need to better understand the factors affecting the health of kidney transplant recipients during this transition. OBJECTIVE To determine the age at which renal transplant recipients are at greatest risk for graft loss. DESIGN, SETTING, AND PARTICIPANTS We performed a retrospective analysis of 168 809 first kidney-only transplant events from October 1987 through October 2010, in recipients up to age 55 years as reported by the Organ Procurement Transplantation Network Standard Transplant Analysis and Research Database. Recipient age at transplant was the primary predictor studied. Confounder and effect modifier covariates were identified and studied using Cox proportional hazard models. EXPOSURE Kidney-only transplant. MAIN OUTCOMES AND MEASURES Patient and renal graft survival, along with death-censored and non―death-censored information. RESULTS A total of 168 809 renal transplant events met the inclusion criteria. Recipients who received their first kidney transplant at age 14 to 16 years were at the highest risk of graft loss, with inferior outcomes starting at 1 and amplifying at 3, 5, and 10 years after transplant. Black adolescents were at disproportionately high risk of graft failure. The variables that had significant interaction with recipient age were donor type (deceased vs living) and insurance type (government vs private). Among 14-year-old recipients, the risk of death was 175% greater in the deceased donor-government insurance group vs the living donor―private insurance group (hazard ratio, 0.92 [95% CI, 0.90-0.94] vs 0.34 [95% CI, 0.33-0.36]), whereas patient survival rates in the living donor―government insurance and deceased donor―private insurance groups were nearly identical (hazard ratio, 0.61 [95% CI, 0.58-0.63] vs 0.54 [95% CI, 0.51-0.56]). CONCLUSIONS AND RELEVANCE Recipients aged 14 to 16 years have the greatest risk of kidney allograft failure. Black adolescents and those with government insurance are at even higher risk. Private insurance reduces risk of death across all ages. Comprehensive programs are needed for adolescents, especially for those at greater risk, to reduce graft loss during the transition from adolescence to adulthood

Kidney and Pancreas Transplantation in the United States, 1996–2005

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/73647/1/j.1600-6143.2006.01781.x.pd

The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update The ISLETS FOR US Collaborative

Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and more than minimally manipulated human cell and tissue products (HCT/Ps). Across the world, human islets are appropriately defined as minimally manipulated tissue which has led to islet transplantation becoming a standard-of-care procedure for patients with type 1 diabetes mellitus and problematic hypoglycemia. As a result of the outdated US regulations, only eleven patients underwent allo-ITx in the US between 2011-2016 and all in the setting of a clinical trial. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both, better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States

Impure Public Goods and Technological Interdependencies

Impure public goods represent an important group of goods. Almost every public good exerts not only effects which are public to all but also effects which are private to the producer of this good. What is often omitted in the analysis of impure public goods is the fact that – regularly – these private effects can also be generated independently of the public good. In our analysis we focus on the effects alternative technologies – independently generating the private effects of the public good – may have on the provision of impure public goods. After the investigation in an analytical impure public good model, we numerically simulate the effects of alternative technologies in a parameterized model for climate policy in Germany

The demise of islet allotransplantation in the United States: A call for an urgent regulatory update

Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and “more than minimally manipulated” human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as “minimally manipulated tissue” and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States

Presence of Urinary Haufen Accurately Predicts Polyomavirus Nephropathy

There are no accurate, noninvasive tests to diagnose BK polyomavirus nephropathy, a common infectious complication after renal transplantation. This study evaluated whether the qualitative detection of cast-like, three-dimensional polyomavirus aggregates (“Haufen”) in the urine accurately predicts BK polyomavirus nephropathy. Using negative-staining electron microscopy, we sought Haufen in 194 urine samples from 139 control patients and in 143 samples from 21 patients with BK polyomavirus nephropathy. Haufen detection was correlated with pathology in concomitant renal biopsies and BK viruria (decoy cell shedding and viral load assessments by PCR) and BK viremia (viral load assessments by PCR). Haufen originated from renal tubules containing virally lysed cells, and the detection of Haufen in the urine correlated tightly with biopsy confirmed BK polyomavirus nephropathy (concordance rate 99%). A total of 77 of 143 urine samples from 21 of 21 patients with BK polyomavirus nephropathy (disease stages A–C) contained Haufen, and during follow-up (3 to 120 wk), their presence or absence closely mirrored the course of renal disease. All controls were Haufen-negative, however, high viremia or viruria were detected in 8% and 41% of control samples, respectively. κ statistics showed fair to good agreement of viruria and viremia with BK polyomavirus nephropathy or with Haufen shedding and demonstrated an excellent agreement between Haufen and polyomavirus nephropathy (κ 0.98). Positive and negative predictive values of Haufen for BK polyomavirus nephropathy were 97% and 100%, respectively. This study shows that shedding of urinary Haufen and not BK viremia and viruria accurately mark BK polyomavirus nephropathy. It suggests that the detection of Haufen may serve as a noninvasive means to diagnose BK polyomavirus nephropathy in the urine