Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01531257 |
| Other study ID # |
STU 25946 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2010 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Northwestern University |
| Contact |
Jairo Chavez, BA |
| Email |
jairo.chavez[@]northwestern.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is
responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy strongly
predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians because
current monitoring tools, namely the serum creatinine concentration, are not sensitive to
early changes in glomerular filtration rate (GFR) or to histologic damage.
Despite advances in prevention of acute rejection (AR), it is still a significant and
potentially devastating complication of solid organ transplantation. One strategy to reduce
the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection
(SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR
can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA.
Kidney biopsies provide better information but are limited due to safety concerns, patient
preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow
early intervention as well as improved graft and better patient outcomes.
This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in a
prospective blood, urine and kidney tissue monitoring study of kidney transplant recipients
who will be scheduled for standard of care biopsies.
Description:
This is a single-center sample study. A total number of 1000 subjects will be consented and
enrolled at Northwestern University Transplant clinic at the time of kidney biopsy. At our
clinic, protocol biopsy may be performed at 3 months, 12 months , 24 months or any other time
the doctor feels necessary post transplant in all kidney recipients. Kidney transplant
recipients may also go under "for cause" biopsy procedure at any time point before/after or
in between these protocol biopsy time points. Such causes of biopsy include increase in serum
creatinine level, decrease in urine output, and/or pain at graft site.
Full blood tube set, urine sample for proteomics and flow cytometry of urinary sediment, and
an extra core kidney biopsy tissue for gene expression profiling will be collected from
subjects at the time of any biopsies obtained during the study course. These specimen samples
will be sent to Rules-Based Medicine (RBM) for proteomic analysis. Whole genome expression
profiling will be done using Affymetrix GeneChips at The Scripps Research Institute.
We estimate that we will find at least 500 subjects with diagnostic CAN/IFTA histology (Banff
1-2) between the 3 months and 12 months post transplant protocol biopsies based on a 50%
incidence in the literature and our own experience. We also estimate that there will be 10%
(10 subjects) incidence of clinical rejection by the end of 12 months identified initially by
an acute rise in the serum creatinine and confirmed by a biopsy. Lastly, we estimate a 10%
(10 subjects) incidence of subclinical acute rejection with stable renal function detected by
the protocol kidney biopsies.
