Measuring Kidney Function in Kidney Transplantation

NCT00212979 | Completed

• 2 other identifiers: PSI Grant R03-59REB Protocol #2003435-01H
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplantation is the preferred treatment for permanent kidney failure. Following transplantation, the kidney function must be followed closely to detect problems so that investigations and appropriate treatment can be started early. Currently, function is monitored with the use of serum creatinine. In clinical trials involving kidney transplant recipients, markers of kidney function, such as serum creatinine, are increasingly being used as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or sensitive at detecting change in kidney transplant function. Newer methods of evaluating kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and cystatin C, are known to be accurate markers of function in patients with non-transplant kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney function with an accepted method (radioisotope clearance study) of measuring true kidney function in 250 renal transplant patients. Each patient will have 2 measurements made at least 3 months apart to determine the accuracy and responsiveness to change over time for the MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate then clinical care and research studies involving transplant patients will be greatly enhanced. Patients and physicians would have a simple test that could detect problems earlier and more precisely monitor response to treatment leading to improved outcomes for renal transplant recipients.

Conditions

Renal Transplant

Keywords

glomerular filtration rate; cystatin C; creatinine

Study Arms (1)

non intervention study

Other: non intervention study

Interventions

non intervention study OTHER

non intervention study

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years of age.
• At least 6 months post-renal transplantation.

You may not qualify if:

• Unable or unwilling to provide informed consent
• Pregnant or breastfeeding
• Acute rejection within the preceding three months
• Likely to die from another comorbid disease within the next three months
• Likely to require dialysis or repeat transplantation within the next three months

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

Study Officials

• Greg A Knoll, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: March 31, 2016

Record last verified: 2009-02

Locations

CA (1)