NCT00270712

Brief Summary

The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,175

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

13.3 years

First QC Date

December 27, 2005

Last Update Submit

October 30, 2019

Conditions

Keywords

kidneytransplantdysfunctionchronicdeteriorationloss of function

Outcome Measures

Primary Outcomes (1)

  • Kidney transplant failure

    throughout study (for prospective cohort)

Study Arms (2)

Retrospective Cohort

537 transplant recipient records used retrospectively

Prospective Cohort

3137 transplant recipients enrolled prospectively

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplant recipients

You may qualify if:

  • Received a kidney transplant within 10 days prior to study entry, on or after 10-01-2005
  • Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
  • Received a kidney transplant before 10-01-2005
  • Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
  • Undergoes a clinically indicated kidney biopsy due to new onset deterioration of function, defined as having an increase in serum creatinine
  • The creatinine level on or before 01-01-2006 must be 2 mg/dl or less OR the patient must have developed new onset proteinuria, defined as having a protein/creatinine ratio of 0.4 or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama - Division of Nephrology

Birmingham, Alabama, 35294, United States

Location

University of Iowa - Nephrology Division

Iowa City, Iowa, 52242, United States

Location

Hennepin County Medical Center - Division of Nephrology

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota Dept of Surgery - Transplantation Division

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic - Division of Nephrology

Rochester, Minnesota, 55905, United States

Location

University of Alberta - Division of Nephrology & Immunology

Edmonton, Alberta, T6G 2S2, Canada

Location

Health Sciences Center - Section of Nephrology

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (6)

  • Hariharan S, Kasiske B, Matas A, Cohen A, Harmon W, Rabb H. Surrogate markers for long-term renal allograft survival. Am J Transplant. 2004 Jul;4(7):1179-83. doi: 10.1111/j.1600-6143.2004.00484.x.

    PMID: 15196079BACKGROUND
  • Kasiske BL, Gaston RS, Gourishankar S, Halloran PF, Matas AJ, Jeffery J, Rush D. Long-term deterioration of kidney allograft function. Am J Transplant. 2005 Jun;5(6):1405-14. doi: 10.1111/j.1600-6143.2005.00853.x.

    PMID: 15888048BACKGROUND
  • Matas AJ, Helgeson E, Fieberg A, Leduc R, Gaston RS, Kasiske BL, Rush D, Hunsicker L, Cosio F, Grande JP, Cecka JM, Connett J, Mannon RB. Risk Prediction for Delayed Allograft Function: Analysis of the Deterioration of Kidney Allograft Function (DeKAF) Study Data. Transplantation. 2022 Feb 1;106(2):358-368. doi: 10.1097/TP.0000000000003718.

  • Grande JP, Helgeson ES, Matas AJ. Correlation of Glomerular Size With Donor-Recipient Factors and With Response to Injury. Transplantation. 2021 Nov 1;105(11):2451-2460. doi: 10.1097/TP.0000000000003570.

  • Oetting WS, Schladt DP, Dorr CR, Wu B, Guan W, Remmel RP, Ikle D, Mannon RB, Matas AJ, Israni AK, Jacobson PA; DeKAF Genomics and GEN03 Investigators. Analysis of 75 Candidate SNPs Associated With Acute Rejection in Kidney Transplant Recipients: Validation of rs2910164 in MicroRNA MIR146A. Transplantation. 2019 Aug;103(8):1591-1602. doi: 10.1097/TP.0000000000002659.

  • Seibert SR, Schladt DP, Wu B, Guan W, Dorr C, Remmel RP, Matas AJ, Mannon RB, Israni AK, Oetting WS, Jacobson PA. Tacrolimus trough and dose intra-patient variability and CYP3A5 genotype: Effects on acute rejection and graft failure in European American and African American kidney transplant recipients. Clin Transplant. 2018 Dec;32(12):e13424. doi: 10.1111/ctr.13424. Epub 2018 Oct 31.

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine specimens.

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Arthur J. Matas, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2005

First Posted

December 28, 2005

Study Start

October 1, 2005

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations