NCT00056784

Brief Summary

This study will examine whether measurements of connective tissue growth factor (CTGF) and other cell proteins can identify which kidney transplant recipients are likely to develop chronic allograft nephropathy (CAN), a disease of the transplanted kidney. CAN may occur months to years after the transplant. The kidney becomes progressively scarred and eventually loses all function, so that dialysis or another transplant is needed. A better understanding of how CTGF and other proteins are involved in the development of CAN may provide new targets for treating for the disease. Patients who are scheduled to receive a kidney or combined kidney-pancreas transplant or who have received a transplant recently (within 6 months) may be eligible for this study. Participants will be enrolled before the transplant, if possible, or after the transplant, and will undergo the following tests and procedures:

  • Physical examinations at the screening visit, at 1, 6, 12, and 24 months, and then once yearly.
  • Blood sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then once yearly.
  • Urine sample collections at the screening visit, at 1, 6, 12, 18, and 24 months and then once yearly.
  • Kidney biopsies at the beginning of the study, at 1, 6, 12, and 24 months, and then once a year for research purposes. Participants may refuse to have a research biopsy at any time during the study. Also, patients who are having a kidney biopsy for another reason at these time points will not have a second biopsy. The biopsy procedure takes about 15 minutes and is done in the hospital. The patient lies on his or her back and the skin over the transplanted kidney is cleaned with alcohol and iodine. The area is numbed with an injection of an anesthetic, and then a biopsy needle is placed through the kin. The biopsy may be repeated up to three times to get enough tissue to test for CAN. Patients lie flat for 4 hours after the procedure to reduce the risk of bleeding, and are observed for another 2 hours for possible complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 20, 2003

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2003

Completed
11.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2014

Completed
Last Updated

October 6, 2017

Status Verified

June 17, 2014

First QC Date

March 22, 2003

Last Update Submit

October 5, 2017

Conditions

Kidney Transplantation

Keywords

TGF-BetaKidneyTransplantationRejectionImmunosuppressionKidney TransplantChronic Allograft NephropathyCAN

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients of living related, living unrelated, and cadaveric kidney transplants.
  • This study will be open to all patients currently enrolled in NIDDK transplant protocols as well as patients recruited from other transplant centers.
  • Ability and willingness to provide informed consent (adults greater than or equal to 18.0 years) or assent (children 4 to 18.0 years).

You may not qualify if:

  • Inability to provide informed consent.
  • Inability to return to NIH for follow-up.
  • Inability or unwillingness to release outside medical records or pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.

    PMID: 10580071BACKGROUND

  • Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. doi: 10.1056/NEJM200003023420901.

    PMID: 10699159BACKGROUND

  • Cecka JM. The UNOS renal transplant registry. Clin Transpl. 2001:1-18.

    PMID: 12211771BACKGROUND

MeSH Terms

Conditions

Camurati-Engelmann SyndromeRejection, Psychology

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSocial BehaviorBehavior

Study Officials

  • Monique E Cho, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 22, 2003

First Posted

March 24, 2003

Study Start

March 20, 2003

Study Completion

June 17, 2014

Last Updated

October 6, 2017

Record last verified: 2014-06-17

Locations

US(1)