IPOS Kidney project resources

This document describes the recipient eligibility requirements for participating in interprovincial kidney sharing. 

Click to view or download the recipient eligibility criteria policy CTR.50.001

Kidney Recipient Eligibility Criteria: A Clinical Guideline

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities for patients who are waiting for a kidney transplant and who are pediatric or highly sensitized to Human Leukocyte Antigens (HLA). This document describes the recipient eligibility requirements for participating in interprovincial kidney sharing.

Policy

1.0 ADULT TRANSPLANT RECIPIENT Eligibility Criteria

To be registered for interprovincial kidney sharing, an adult transplant recipient must meet the following criteria:

• 1.1 The patient must be 19 years of age or older. A patient is considered an adult at 00:00 (Pacific Time) on their 19th birthday.
• 1.2 The patient must have an unadjusted cPRA value ≥ 94.5%
• 1.3 The patient must be undergoing chronic hemodialysis or peritoneal dialysis.
  • 1.3.1 OR: A patient may be listed pre-emptively if their unadjusted cPRA is ≥ 99.5% and if their eGFR is <15 ml/min/1.73m² using CKD-EPI 2021 formula.
• 1.4 The patient must be wait-listed for a kidney transplant at a Canadian transplant centre.

2.0 PEDIATRIC TRANSPLANT RECIPIENT Eligibility Criteria

To be registered for interprovincial kidney sharing, a pediatric transplant recipient must meet the following criteria:

• 2.1 The patient must be under 19 years of age. A patient is considered pediatric up until 00:00 (Pacific Time) on their 19th birthday.
• 2.2 The patient must have an unadjusted cPRA value ≥ 94.5%
  • 2.2.1 OR: The pediatric patient may be listed with a cPRA < 94.5% only if they are looking for a Class II (DRB1, DQA and DQB) 0/6 mismatch offer.
• 2.3 The patient must be undergoing chronic hemodialysis or peritoneal dialysis.
  • 2.3.1 OR: Pediatric patients may be listed pre-emptively if their eGFR is <15 ml/min/1.73m2, using revised bedside Schwartz formula, on 2 consecutive measurements at least 2 months apart.
    • 2.3.1.1 The patient’s eligibility should be reviewed every 3 months.
    • 2.3.1.2 Note: Pediatric patients are ineligible pre-emptively if they have an approved compatible living kidney donor.
• 2.4 The patient must be wait-listed for a kidney transplant at a Canadian transplant center.

3.0 Citizenship and Residency Requirements

In addition to 1.0 and 2.0 Recipient Eligibility Criteria, the recipient must be:

• 3.1 A Canadian citizen or permanent resident who is eligible under a provincial, territorial or federal health insurance program;
• 3.2 A foreign citizen who is covered under a provincial, territorial, or federal health insurance program while residing in Canada (e.g. Temporary Foreign Workers, Refugees, Foreign Diplomats, International Students);
• 3.3 A foreign citizen who is legally residing in Canada and has private insurance coverage (e.g. tourist in an emergency situation, International Students, Foreign Diplomats)
  • 3.3.1 Such cases would be at the discretion of the local program, and handled on a case-by-case basis

4.0 Participation in International Registries

• 4.1 Canadian citizens and permanent residents who have received approval by their respective provincial or territorial government for out-of-country health services specific to participating in an international registry, are also eligible to be registered in the CTR.
  • 4.1.1 The international registry listing should be noted in the individual’s record. If the individual is identified for transplant through a foreign registry, they must be immediately inactivated in the CTR.

This document describes the procedure with respect to offering kidneys under the HSP registry. 

Click to view or download the requirement to offer policy CTR.50.002

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities for patients who are waiting for a kidney transplant and who are pediatric or who are highly sensitized to Human Leukocyte Antigens (HLA).  Provincial donation and transplantation programs/agencies who participate in the IPOS Kidney program have committed to offering kidneys to highly sensitized patients who are matched through the IPOS kidney registry matching process.  This document describes the procedure with respect to offering kidneys under the IPOS kidney registry. 

Policy

1.0 IPOS Kidney Offer Requirements

• 1.1 All consented deceased donors will be entered into the CTR. 
• 1.2 Provinces participating in the IPOS Kidney registry will make available to the registry one donor kidney from each deceased donor that has two kidneys deemed to be transplantable.
  • 1.2.1 When a donor kidney is available to the registry a ranked listing of all potential kidney recipient matches will be generated by the registry.
  • 1.2.2 The donor program/agency is obliged to make an offer to the first recipient on the list. If this is declined, an offer is made to the second, then third, and subsequent recipients on the list.
  • 1.2.3 The obligation to offer a kidney to a matched HSP recipient includes both in-province and out-of-province proposed matches as identified and ranked by the CTR.
  • 1.2.4 Should the potential recipient be listed for both a kidney and pancreas – only the kidney would be subject to the mandatory offer through the IPOS Kidney Registry.
  • 1.2.5 The decision to offer the pancreas or any other organ, should this be a multi organ listing, would be an optional discussion between the respective programs/agencies.
  • 1.2.6 Programs/agencies receiving IPOS Kidney offers have 120 minutes (2 hours) from the time the verbal offer is made, to accept or decline an offer.
    • 1.2.6.1 If the donor (offer) centre does not hear back within 120 minutes from making the offer as to whether the potential recipient centre has accepted or declined the offer, the donor centre should notify the recipient centre that they are proceeding to make an offer to the next ranked HSP recipient/centre.
  • 1.2.7 Phone conversations to confirm the offer must occur between donor coordinators and between HLA laboratories involved.
    • 1.2.7.1 The nature of the donor coordinator conversations is to review donor information, determine donor kidney acceptability, and other relevant logistics.
    • 1.2.7.2 The nature of the HLA laboratory conversations is to discuss pertinent aspects to determine the HLA match.  This conversation should occur as soon as possible after the offer is made.
    • 1.2.7.3 If there are specific surgical requirements, surgeon to surgeon communication is recommended.  

2.0 Exceptions to Offer Requirements

• 2.1 There is no requirement to offer through the IPOS Kidney registry allocation process when:
  • 2.1.1 The donor has only one transplantable kidney.
  • 2.1.2 There are no compatible recipients on the IPOS Kidney registry list.
  • 2.1.3 There are multiple medically urgent patients on the provincial waitlist of the program/agency who match the deceased donor. (Medically urgent is defined in CTR.50.003 Matching and Ranking Methodology: Kidney.)
  • 2.1.4 The kidney cannot be safely transplanted due to the likelihood of an extended cold ischemic time based on the risk assessment of the ranked program (s) receiving the offer.

3.0 Management of the Non-match Allocated Kidney

• 3.1 Should a recipient centre receive a kidney but be unable to transplant it into the IPOS Kidney designated recipient, the recipient centre may allocate the kidney:
  • 3.1.1 First to another recipient patient from their centre participating in the IPOS Kidney registry;
  • 3.1.2 Secondly, any other suitable recipient in that centre or province according to provincial allocation policy. 

4.0 Kidney No-Longer Deemed Transplantable

• 4.1 Should the kidney be received by the recipient centre and deemed non-transplantable, the receiving donor coordinator should:
  • 4.1.1 Inform the donor centre coordinator and determine if there are specific legal requirements to return the organ to the donor centre.
  • 4.1.2 Dispose of the organ according to provincial biological waste policies.
     

This policy outlines the matching algorithm rules used to identify and rank paediatric and highly sensitized patients (HSP) who are potential matches to an available deceased donor kidney. 

Click to view or download the matching and ranking policy CTR.50.003

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities across Canada for kidney transplant candidates who are pediatric or highly sensitized to Human Leukocyte Antigens (HLA). This policy outlines the matching algorithm rules used to identify and rank pediatric and highly sensitized patients (HSP) who are potential matches to an available deceased donor kidney.

Policy

1.0 Identifying Potential Recipient Matches

There are three tiers of matching and ranking that the kidney algorithm performs to develop a final listing of potential pediatric and HSP recipient matches for a deceased donor who has been registered in the CTR. 

The tree tiers are:

• Blood Group Compatibility
• HLA Compatibility
• Recipient and Transplant Program-specific filter

• 1.1 Blood Group Compatibility
  • 1.1.1 Eligible potential kidney recipients are first matched for blood group compatibility, and then for HLA compatibility.

Blood Group (ABO) Compatibility

• 1.2 HLA Compatibility
  • 1.2.1 Potential matches are excluded when the deceased donor has HLA antigens that have been listed in the potential kidney recipient’s record as being unacceptable.  
  • 1.2.2 Currently allele-specific antigens are identified by the algorithm and flagged for investigation by HLA lab director or delegate, but do not screen out potential matches.
  • 1.2.3 For potential kidney recipient’s with cPRA ≥ 99.0% their HLA lab, in consultation with their transplant program, can indicate certain antigens as Willing to Cross. Both an adjusted cPRA (after removal of Willing to Cross antigens) and unadjusted cPRA will be used for ranking.

• 1.3 Recipient and Transplant Program/Agency Specific Filters
  • 1.3.1 Optional filters can be applied by a transplant program/agency for the potential kidney recipients listed by that program, based on an assessment of the potential recipient’s individual needs or preference(s) of the transplant program/agency.
  • 1.3.2 The kidney matching algorithm will exclude potential matches based on filters entered for the specific potential kidney recipient. The following filters can be turned on or off and values can be added within specified ranges.

• 1.4 Pediatric Class II Matching
  • 1.4.1 Non-HSP pediatric candidates receive a possible match only when there is a zero mismatch between donor and candidate at DRB1, DQA and DQB loci. 

2.0 Ranking of Matched Potential Recipients

• 2.1 If more than one potential kidney recipient is a match for a deceased donor kidney, matches are prioritized based on the following ranking criteria.

• 2.1.1 Transplant Programs can list potential kidney recipients as Medically Urgent in CTR if they are approved for and actively listed as Medically Urgent on a deceased donor waitlist by the local Transplant Program.
  • 2.1.1.1 The potential kidney recipient’s sponsoring physician submits data to document the factors that have resulted in the Medically Urgent status using, “Canadian Transplant Registry - Medical Urgency Data Collection Form”.
  • 2.1.1.2 The “Canadian Transplant Registry - Medical Urgency Data Collection Form” will be audited annually and as needed, by the Kidney Transplant Advisory Committee (KTAC).
• 2.1.2 There is pre-emptive listing allowed for pediatric patients participating in the interprovincial kidney program. See policy CTR.50.001 for eligibility requirements for pediatric recipients.
• 2.1.3 The kidney-pancreas patient will receive a priority ranking score only in the event of an offer that includes the transplantable pancreas with the kidney.

3.0 Approval of HSP Allocation Methodology

The kidney allocation methodology, including the cPRA cut-off value, will be reviewed bi-annually by the Kidney Transplant Advisory Committee (KTAC).

This policy describes the process for managing the number of kidneys shared between provinces under the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program. Inter-provincial balancing ensures equitable sharing of kidneys among participants of the HSP Program by maintaining thresholds limiting the number of exports of kidneys by any one province.

Click to view or download the interprovincial balancing policy CTR.50.004

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities across Canada for patients who are waiting for a kidney transplant and who are pediatric or who are highly sensitized to Human Leukocyte Antigens (HLA). This policy describes the process for managing the number of kidneys shared between provinces under the Interprovincial Sharing: Kidney (IPOS) program. Interprovincial balancing ensures equitable sharing of kidneys among participants of the IPOS Kidney Program by maintaining thresholds limiting the number of exports of kidneys by any one province.  

Policy

1. Exports and Imports

• 1.1 An export is counted once a kidney(s) is/are procured, determined to be of transplantable quality by the originating site, and left the donor center with the intent of being shipped to a transplant centre that has accepted the kidney, regardless of whether the kidney is ultimately transplanted into the designated recipient or another recipient or not transplanted at all. 
  • 1.1.1 Export counts are awarded to the province/region of the donor’s Organ Donation Organization (ODO).
  • 1.1.2 One export is counted per kidney shipped except in the case of an en bloc or double kidney offer where a single recipient receives both kidneys, in which case only a single export is counted.
  • 1.1.3 If an offer of an en bloc or double kidney is accepted for a single recipient and subsequently transplanted into two different recipients, two exports (and two imports) are counted.
• 1.2 An import¹ is counted once a kidney/kidneys is/are transplanted, regardless of whether the kidney (s) is/are transplanted into the designated recipient or a different recipient.
  • 1.2.1 Import counts are awarded to the province/region of the recipient’s Provincial Health Number (PHN).
• 1.3 If the kidney is shipped but not transplanted, the export is counted but the import is not counted.

2. Export Threshold

• 2.1 To facilitate interprovincial balancing, thresholds are established for each province/region²  as an upper limit of the number of kidneys they are obliged to export (out of province) under the HSP Program.
• 2.2 The export threshold for each province/region is determined based on a percentage of its three year average number of deceased kidney donors. Thresholds are currently set at 5% of each province/region’s deceased donor averages as reported by the Canadian Organ Replacement Registry (CORR).

¹There is no upper limit to imports (i.e., import threshold). Although imports are not considered in interprovincial balancing, they are tracked for the purpose of monitoring interprovincial activity and net import/export activity.

²Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador participate in the inter-provincial balancing as one region, Atlantic Canada.

3. Offer Requirement When at Export Threshold

• 3.1 The CTR identifies and ranks all potential recipients who match with a donor. Upon presenting potential recipient matches, the CTR alerts the user to the export balance for the donor province/region, if applicable. 
• 3.2 A province/region must offer a donor kidney if its export balance is less than its export threshold.

4. Inter-Provincial Balances

• 4.1 The CTR is programmed to provide a real-time balance of interprovincial kidney transfers. A Balancing Report is available on-line in the CTR, or by request to the CTR Customer Solutions team to provide real-time balances and activity by province/region.
• 4.2 A province/region’s interprovincial balance is the net of all imports less exports since the launch of the Interprovincial Sharing: Kidney program.
  •  4.2.1 A positive balance (e.g., +3) indicates a greater number of imports than exports.
  • 4.2.2 A negative balance (e.g., -2) indicates a greater number of exports than imports. (Example:  Province A has imported 11 kidneys and exported 13 kidneys since the launch of Interprovincial Sharing: Kidney program. Its balance is -2.)
• 4.3 Balances are between a province/region and the rest of Canada, not between 2 provinces/regions.
  • 4.3.1 The balance accounts for only those interprovincial transfers that take place through participation in the Interprovincial Sharing: Kidney program. All kidney allocations that take place outside the program are not counted.
• 4.4 To minimize organs being shipped unnecessarily, the matching algorithm for the Interprovincial Sharing: Kidney program gives priority to recipients in the same province/region as the donor.
  • 4.4.1 Kidney allocations within the same province/region as the donor have no net effect on imports, exports, or balancing, even though it may occur as part of the Interprovincial Sharing: Kidney program. 

5. Governance

• 5.1 This Interprovincial Balancing Policy, including provincial/regional thresholds, will be reviewed bi-annually, at a minimum, by the Kidney Transplant Advisory Committee (KTAC).
• 5.2 Policy changes may be proposed by Canadian Blood Services, KTAC, or any participating province/region.
• 5.3 Requests for review of proposals or modifications to HSP balancing should be made to Canadian Blood Services.
• 5.4 Any disputes regarding HSP balancing should be referred to Canadian Blood Services for analysis and, if required, consideration by the KTAC

This document describes, for Transplant Programs who wish to seek additional opportunities for highly sensitized patients, the protocols and recommendations to use in identifying antigens that can be crossed.

Click here to view or download the willing to cross antigens policy CTR.80.002

Willing to Cross Antigens in HIGHLY SENSITIZED Patients: A CLINICAL GUIDELINE

Purpose

The Kidney Paired Donation (KPD) and Highly Sensitized Patient (HSP) programs identify transplant opportunities for patients who are waiting for a kidney transplant. However, despite these registries, a number of transplant candidates are unable to find a compatible donor. This is usually due to a very high cPRA 99-100%. This document describes, for Transplant Programs who wish to seek additional opportunities for these patients, the protocols and recommendations to use in identifying antigens that can be crossed.

Policy

1. Recipient Suitability for Willing to Cross Consideration

• 1.1 Consideration for ‘Willing to Cross’ must align with local clinical policy and practices.
• 1.2 The transplant program is responsible for identifying potential candidates, for ‘Willing to Cross’ from their local transplant waitlist.
• 1.3 Patients to be considered for ‘Willing to Cross’ could be enrolled in either the KPD or HSP programs, or both.
• 1.4 Initial recommendation for ‘Willing to Cross’ is to start with the ≥99.0% cPRA patients enrolled in the KPD and HSP programs.

2. Procedures

• 2.1 HLA laboratory must record ‘Willing to Cross’ antigens.
• 2.2 For each ‘Willing to Cross’ antibody specificity, the HLA Laboratory must indicate all reasons for the WTC designation.

3. Willing to Cross for HSP program

• 3.1 HSP program eligibility is based on the adjusted cPRA ≥94.50% or unadjusted cPRA ≥94.50%
• 3.2 The adjusted cPRA is the cPRA after ‘Willing to Cross’ antigens are removed and is relevant for the current allocation, if the offer requires ‘Willing to Cross’ to be used.
• 3.3 The unadjusted cPRA is the cPRA without any ‘Willing to Cross’ antigens being removed.
• 3.4 The adjusted cPRA must be ≥ 94.50% in order for the transplant candidate to remain eligible for the HSP Program.
• 3.5 If ‘Willing to Cross’ is enabled for the HSP program, then the blood group, HLA and other optional matching filters must remain the same for transplant candidates with adjusted and unadjusted cPRA. Refer to CTR.50.003 HSP – Matching and Ranking for the detailed HSP program matching rules.
• 3.6    If ‘Willing to Cross’ is enabled for the HSP program, then a transplant candidate with an unadjusted cPRA must rank higher than a transplant candidate with an adjusted cPRA of the same value. Refer to CTR.50.003 HSP – Matching and Ranking for the detailed HSP program ranking rules.
• 3.7 In the adjusted cPRA tier, a higher cPRA must be ranked above a lower cPRA
• 3.8 In the unadjusted cPRA tier, a higher cPRA must be ranked above a lower cPRA
• 3.9 Please refer to the Willing to Cross Guidelines for up-to-date recommendations.

4. Willing to Cross for KPD Program

• 4.1 For the KPD program, if the adjusted cPRA < 94.5% then the transplant candidate does not receive the “Highly Sensitized (cPRA ≥ 94.5%)” match points.

5. Post-Transplant Outcome Data

• 5.1 The ‘Willing to Cross’ data will be reviewed bi-annually, at a minimum, by the National HLA Advisory Committee (NHLAAC) and Kidney Transplant Advisory Committee (KTAC).
• 5.2 The post-transplant outcome information is required at the following time points: 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months.
• 5.3 Information required for HSP and KPD recipient’s post-transplant outcome includes:
  • a. DSA (de novo and pre-existing) and MFI testing at:
    • i. Day of transplantation
    • ii. Week 1 and 2 following transplant
    • iii. Serum samples should be collected at the following intervals to be stored for further testing as needed
      • Month 1, 3, 6, 12 following transplant
      • Yearly thereafter
    • iv. at time of indication biopsy
      v. Clinical suspicion of rejection
      vi. at time of AMR diagnosis
  • b. Virtual crossmatch absolute value
  • c. Protocol biopsy at 3 months; if done within 8 weeks no need to repeat at 3 months
  • d. indication biopsy at any time point for the following reasons:
    • i. Development of new DSA
    • ii. Recurrence of historical DSA that was not present at time of transplant
    • iii. Significant increase in DSA; as per consultation with HLA lab
    • iv. If estimated Glomerular Filtration Rate </= 20ml/min at 6-8 weeks post-transplant and no biopsy done in prior 2-4 weeks; in absence of other predictors of poor graft function
    • v. Delayed graft function as per centre standard, ideally within the first 7-10 days post-transplant
    • vi. Any other clinically indication as per treating physician
  • e. Polyoma (BK)viremia in first 12 months events that required a change in clinical immunosuppression management
  • f. Biopsy proven AMR
  • g. Biopsy proven T-cell mediated rejection
  • h. Serum creatinine
    • i. week 1, 2, 3
    • ii. month 1, 3, 6, 12
    • iii. yearly
    • iv. at time of AMR diagnosis and 1-month post
  • i. Delayed Graft Function (defined as need for 2+ dialysis treatments within the first 7-10 days; excluding a single session for hyperkalemia and/or fluid overload)
  • j. Graft failure and cause, if applicable
  • k. Patient death and cause, if applicable
  • l. Inform Canadian Blood Services via normal business process if kidney is transplanted to unintended backup recipient
• 5.4 The Kidney Transplant Advisory Committee can work with clinical transplant programs to ensure that this outcome data is entered in the survey sent by Canadian Transplant Registry and Interprovincial Organ Sharing program.
• 5.5 NHLAAC and KTAC will review ‘Willing to Cross’ outcome data over time and discuss challenging cases as they occur.

6. Review

• 6.1 This policy may be reviewed on recommendations by the NHLAAC or KTAC.