Kidney Transplant Failure

NCT01296061 | Terminated

• 1 other identifier: CIHR FRN MOP-102732
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Hypotheses:

1. 1.Among patients who retain the failed kidney transplant, those who continue immunosuppressant medication will have more deaths than patients who discontinue these drugs
2. 2.Among patients who retain the failed kidney transplant, those who continue immunosuppressant medication will have more hospitalizations for sepsis than patients who discontinue these drugs
3. 3.Among patients who retain the failed kidney transplant, those who continue immunosuppressant medication will have fewer rejection events than patients who discontinue these drugs
4. 4.Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will have fewer deaths than those who retain the failed kidney transplant
5. 5.Patients who undergo elective nephrectomy (to remove the failed kidney transplant) will have fewer hospitalizations for sepsis than those who retain the failed kidney transplant
6. 6.Among patients who retain the failed kidney transplant, those who continue immunosuppressant medication will have lower levels of allosensitization (anti-HLA antibodies) than those who discontinue these drugs
7. 7.Patients who undergo elective nephrectomy will have higher levels of allosensitization (anti-HLA antibodies) than patients who retain the failed kidney transplant

Conditions

Acute Graft Rejection; Renal Failure Chronic Requiring Dialysis

Keywords

Dialysis; Renal Transplantation; Failure of allograft

Outcome Measures

Primary Outcomes (4)

• Death

  Death: Death will be identified through monthly contact of study coordinators with the treating dialysis center. Date of death will be obtained from records maintained by dialysis programs. If required, the patient's treating physician may contact the next of kin to confirm the date of death.

  48 months

• Sepsis

  Sepsis: Hospital discharge records will be reviewed for the most responsible diagnosis. Hospitalizations for sepsis will be identified if an infection is recorded as the primary or secondary discharge diagnosis, and confirmatory laboratory evidence of infection (i.e. positive culture or chest radiograph compatible with pneumonia) is present. In the absence of laboratory evidence of infection, documentation of clinical sign or symptoms of infection will be required (fever, shock, localizing symptoms). The source of infection (e.g. catheter related, urinary tract etc) will be documented.

  48 months

• Rejection of failed allograft.

  Rejection of failed allograft: After transplant failure, rejection is rarely confirmed by a biopsy of the allograft. Rejection events will be identified by patient interview and clinical chart review during follow up visits. Rejection will be identified when both a diagnosis of rejection with compatible signs/ symptoms is documented and either an increase in immunosuppressant drugs is prescribed, or transplant nephrectomy is performed. Only rejection events diagnosed after the initiation of dialysis will be included.

  48 months

• Allosensitization

  Allosensitization: Serum samples will be collected at baseline and at each study visit. Dialysis centers routinely collect serum samples for monitoring allosensitization in wait-listed transplant candidates and have established local protocols for collection, storage and shipping. Both class I and class II Anti-HLA antibodies will be appraised using FlowPRA®.

  48 months

Study Arms (1)

Failed Kidney Transplant

Adults ≥ 18 years, initiating chronic dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 18 years, who initiate chronic dialysis treatment after failure of a first kidney transplant

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• St. Paul's Hospital, Canada: collaborator
• Vancouver General Hospital: collaborator
• Kingston Health Sciences Centre: collaborator
• University of Saskatchewan: collaborator
• University of Calgary: collaborator
• University of Manitoba: collaborator
• University Health Network, Toronto: collaborator
• Unity Health Toronto: collaborator
• St. Joseph's Healthcare Hamilton: collaborator
• London Health Sciences Centre: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Maisonneuve-Rosemont Hospital: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• CHU de Quebec-Universite Laval: collaborator
• University of Alberta: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Class I and II HLA antibodies

Study Officials

• Greg Knoll, MD

  U of Ottawa, The Ottawa Hospital, OHRI

  PRINCIPAL INVESTIGATOR

• John Gill, MD

  UBC, St Paul's Hospital Vancouver, BC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 15, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: July 1, 2017
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

CA (1)