Acute Rejection (AR) of Transplanted KidneyMini-KidneyNCT01531257
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
An observational study of Acute Rejection (AR) of Transplanted Kidney and Chronic Allograft Nephropathy (CAN), run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN), Interstitial Fibrosis (IF)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present for routine care kidney transplant biopsies to the Comprehensive Transplant Center and who satisfy all of the eligibility criteria are approached for this research study.
Who may be able to join
- Male and female recipients of all races, ≥18 years of age.
- Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
- Subject and/or guardian must be able to provide informed consent.
- Subject and/or guardian must be able to comply with the study protocol.
Who cannot join
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Inability or unwillingness of a participant and/or guardian to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martha Castellini, BA contact
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Martha Castellini, BA, martha.castellini@northwestern.edu
Sook H Park, MD
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN), Interstitial Fibrosis (IF), Tubular Atrophy (TA)
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients | The intention of our biomarker panel is to be broadly applicable to all patients with a kidney transplant with the assumption that there are common underlying molecular mechanisms of AR and CAN/IFTA that can be detected hopefully at early stages of disease. We therefore want to validate and test our biomarker panel in a broad collection of patient types. We chose not to include patients with dual organ transplants so that we could isolate the molecular signal we are studying. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression Profiling
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. Whole genome expression profiling will be done using Affymetrix GeneChips at The Scripps Research Institute.
Measured: At time of any protocol or for-cause kidney biopsy, up to 10 years post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startApr 2010
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Rejection (AR) of Transplanted KidneyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Responsible party
- Principal investigator, Sook Hyeon Park, Northwestern University
- Investigators
- Sook H Park, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531257
- Sponsor's protocol ID
- STU 25946
- Acronym
- Mini-Kidney
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2012
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Singla A, Park S, Pedamallu H, Chen K, Robelly B, Rebello C, Lantz C, Zhao L, LaCombe R, Sinha R, Hanna G, Kleiboeker S, Mehrotra S, Friedewald J. Diagnostic Performance and Resource Utilization of Combining Blood Gene Expression, Cell-Free DNA, and Urine Chemokines for Monitoring Kidney Rejection. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1414-1428. doi: 10.2215/CJN.0000001075. Epub 2026 May 21.
PubMed 42166233Fleming JN, Taber D, Heilman RL, Poggio E, Marsh C, Kurian S, Zhao L, Gebregziabher M, Kleiboeker S, Friedewald JJ. Association of Noninvasive Rejection Biomarkers with 10-Year Kidney Allograft Survival. Kidney360. 2026 Aug 1;7(8):1864-1872. doi: 10.34067/KID.0000001167. Epub 2026 Mar 3.
PubMed 41774503
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01531257
- Acronym / sponsor ID
- Mini-Kidney / STU 25946
- Conditions
- Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN), Interstitial Fibrosis (IF), Tubular Atrophy (TA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Study start
- Apr 2010
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Recipients | – | –The intention of our biomarker panel is to be broadly applicable to all patients with a kidney transplant with the assumption that there are common underlying molecular mechanisms of AR and CAN/IFTA that can be detected hopefully at early stages of disease. We therefore want to validate and test our biomarker panel in a broad collection of patient types. We chose not to include patients with dual organ transplants so that we could isolate the molecular signal we are studying. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present for routine care kidney transplant biopsies to the Comprehensive Transplant Center and who satisfy all of the eligibility criteria are approached for this research study.
Key inclusion criteria (4 listed)
- Male and female recipients of all races, ≥18 years of age.
- Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
- Subject and/or guardian must be able to provide informed consent.
- Subject and/or guardian must be able to comply with the study protocol.
Key exclusion criteria (4 listed)
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Inability or unwillingness of a participant and/or guardian to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene Expression Profiling
Time frame: At time of any protocol or for-cause kidney biopsy, up to 10 years post transplant.
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. Whole genome expression profiling will be done using Affymetrix GeneChips at The Scripps Research Institute.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 42166233Singla A, Park S, Pedamallu H, Chen K, Robelly B, Rebello C, Lantz C, Zhao L, LaCombe R, Sinha R, Hanna G, Kleiboeker S, Mehrotra S, Friedewald J. Diagnostic Performance and Resource Utilization of Combining Blood Gene Expression, Cell-Free DNA, and Urine Chemokines for Monitoring Kidney Rejection. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1414-1428. doi: 10.2215/CJN.0000001075. Epub 2026 May 21.
- Derived from this study: PubMed 41774503Fleming JN, Taber D, Heilman RL, Poggio E, Marsh C, Kurian S, Zhao L, Gebregziabher M, Kleiboeker S, Friedewald JJ. Association of Noninvasive Rejection Biomarkers with 10-Year Kidney Allograft Survival. Kidney360. 2026 Aug 1;7(8):1864-1872. doi: 10.34067/KID.0000001167. Epub 2026 Mar 3.
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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.
Martha Castellini, BA contact
Sook H Park, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rejection (AR) of Transplanted Kidney and Chronic Allograft Nephropathy (CAN), run by Northwestern University 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Castellini, BA (martha.castellini@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Profiling (time frame: At time of any protocol or for-cause kidney biopsy, up to 10 years post transplant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531257, which also lists 2 linked publications.
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 5 May 2026.