Case series / case reportindependent cross-checkabstract checked I-SRC-118 standard review
A few kidney recipients keep working kidneys without drugs
The natural history of clinical operational tolerance after kidney transplantation through twenty-seven cases.
Overview
Brouard S et al.. Am J Transplant 2012 · PMID 22974211 · DOI 10.1111/j.1600-6143.2012.04249.x
27 rare patients had stable kidneys off drugs, but almost a third later lost function slowly.
Does the study support the specific claim? Partly · Methodological quality: low
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Describe patients who tolerate a kidney without drugs
- How was the study done?
Comparison of a rare cohort with other patients
- How many people, animals or samples were studied?
27 tolerant patients
- What was actually found?
Most kept function for years; 30% slowly deteriorated
- How large was the observed effect?
19/27 stable at mean 9 years
- What do the results mean in everyday life?
Such cases exist but are rare and cannot be predicted
- What are the study's limitations?
Only successes counted
- What does it say about Elawady's specific claim?
A rare exception, not a basis for stopping drugs
- Do the results apply to Germany and Europe?
European data
- What can explicitly not be concluded from this study?
How many people who stop drugs keep their kidney
Scientific in-depth review
1. Full reference
- Authors
- Brouard S et al.
- Journal
- Am J Transplant
- Year
- 2012
- Identifier
- PMID 22974211 DOI 10.1111/j.1600-6143.2012.04249.x
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works record checked
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
No COI statement in record.
2. Research question
What characterises kidney-transplant recipients who keep stable graft function after stopping immunosuppression, and what happens to them over time?
3. Study design and population
- Study design
- Case series / case report – Cohort description of 27 operationally tolerant kidney recipients compared with matched cohorts
- Population
European kidney recipients with operational tolerance (off immunosuppression with stable function), plus comparison cohorts
- Country
Europe (multicentre)
- Period
Published 2012
- Sample size
27 tolerant patients plus two comparison cohorts
- Inclusion and exclusion criteria
Operational tolerance at inclusion
4. Methods and endpoints
- Exposure / intervention
Immunosuppression stopped (mostly for non-adherence or medical reasons)
- Comparator
Recipients under immunosuppression; patients who stopped drugs and rejected
- Endpoints
Graft function, histology, donor-specific antibodies
- Statistical methods
Group comparisons
5. Actual results
- Results
19 of 27 tolerant patients still had stable graft function (mean 9 ± 4 years after transplantation); 30% showed slow deterioration of graft function; half of biopsied patients showed an active immune mechanism associated with DSA. Tolerant patients more often had no induction therapy and were older at transplantation and at withdrawal than those who rejected after weaning.
- Absolute risks
Not applicable (no denominator of all patients who stopped drugs).
- Authors' conclusion
Operational tolerance can persist, but graft loss does occur in some patients, particularly with donor-specific antibodies.
6. Strengths
- Long follow-up of a rare group
- Comparison with patients who rejected after stopping
7. Weaknesses
- Highly selected survivors; the number of patients who stopped drugs and lost their graft is not the denominator
- No prospective withdrawal protocol
8. Risk of bias
- Orienting tool
- none applicable
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- high
- Rationale
Selection of patients defined by a favourable outcome.
9. Assessment of the statistical interpretation
Cannot estimate how often stopping drugs is tolerated, because only successful cases are counted.
10. Relevance to the specific claim
The strongest 'supporting' evidence: a small number of recipients do keep working kidneys off all drugs. It also shows that this is rare, unpredictable and not always durable.
11. Independent contrary findings
I-INTB-09 (graft failure after non-adherence), I-SRC-102 (rejection after tacrolimus withdrawal).
12. Transferability to Germany and Europe
European cohort.
13. Overall methodological judgement
Shows the phenomenon exists in rare cases; does not justify stopping drugs in an individual patient.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | low |
| Risk of bias | high |
| Precision of results | low |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
How to identify tolerant patients prospectively.