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Protocol biopsies (PBs) are done at different time points after transplant to explore any signs of damage to the allograft without manifesting clinically. There are no consensus guidelines on use of protocol biopsies or specific time points to perform a PBs but literature suggests that findings of PBs may be a guide to long term graft outcomes. We studied the results of PBs done in living donor kidney transplant (LDKT) to explore the frequency of various clinical conditions that could be detected by protocol biopsies.
We collected the reports of protocol biopsies done after completion of 6 months of kidney transplant surgery. Among the 203 patients who had kidney transplants done between 27 Oct 2021 and 29 May 2024, 119 underwent protocol biopsy. Nineteen others had indication biopsy and 65 didn’t have biopsy at all. We collected and entered relevant information to Microsoft Excel and performed descriptive analysis
Two hundred and three kidney transplants were performed between 27 Oct 2021 and 29 May 2024. Characteristics of these transplant patients are shown in Table 1.
Table 1. Characteristics of transplant population
SN
Characteristic
Classification
Number (%)
Total Number
203
1
Age (in years)
Mean
35.56
Range
15–67
2
Sex
Male
158 (77.83%)
Female
45 (22.17%)
3
Donor Relation
Parent
89 (43.84%)
Spouse
70 (34.48%)
Siblings
24 (11.82%)
Others
20 (9.85%)
4
Cause of ESRD
IgAN
30 (14.78%)
DKD
9 (4.43%)
Obstructive Uropathy
8 (3.94%)
FSGS
7 (3.45%)
PCKD
2(0.99%)
MPGN
1(0.49%)
Membranous GN
Anti-GBM
ANCA Vasculitis
Analgesic nephropathy
Undetermined
142 (69.95%)
ANCA, antineutrophil cytoplasmic antibodies; DKD, diabetic kidney disease; ESRD, end stage renal disease; FSGS, focal segmental glomerulosclerosis; GBM, glomerular basement membrane; GN, glomerulonephritis; IgAN, Immunoglobulin A Nephropathy, MPGN, membranoproliferative glomerulonephritis; PCKD, polycystic kidney disease
Out of this, 119 underwent PBs. Another 19 underwent indication biopsies. Other 65 patients didn’t have a biopsy at all. (Table 2.)
Table 2. Number of allograft biopsies
Preprocedure characteristics.
None of our PB candidates had received any pretransplant desensitization treatment. All patients had their first transplant. All were on tacrolimus, MMF, and prednisolone maintenance therapy at the time of biopsy. Main characteristics of our surveillance biopsy population are presented in Table 3.
Table 3. Characteristics of surveillance biopsy population
SNo
Findings (N=119)
Mean age at transplantation (years)
34.85
88 (73.95%)
31 (26.05%)
HLA Mismatch Level
0
10 (8.4%)
<=3/6
75 (63.02%)
>3/6
34 (28.57%)
82(68.91%)
18(15.13%)
1(0.84%)
Obstructive
4(3.36%)
Membranous Nephropathy
5(4.20%)
Analgesis Nephropathy
Anti-GBM Disease
5
Average tacrolimus trough level (ng/ml)
at 1 month
10.783
at 3 months
9.443
at 6 months
8.24
at biopsy
7.33
6
Induction agent
ATG
111
Basiliximab
8
7
Donor relation
57
32
Sibling
17
Other
13
ATG, Anti-thymocyte globulin; ANCA, antineutrophil cytoplasmic antibodies; DKD, diabetic kidney disease; ESRD, end stage renal disease; FSGS, focal segmental glomerulosclerosis; GBM, glomerular basement membrane; GN, glomerulonephritis; HLA, human leucocyte antigen ; IgAN, Immunoglobulin A Nephropathy, MPGN, membranoproliferative glomerulonephritis; PCKD, polycystic kidney disease;
Biopsy findings
Normal findings. Of the 119 PBs, 59 (49.58%) revealed normal findings. (Table 2)
Abnormal findings. Of the 119 biopsies, 57 (47.89%) samples showed some abnormality. (Table 2) The findings of biopsies have been summarized in Table 4.
Table 4. Results of surveillance biopsy
S.No
Diagnosis
Total (N)
Detected by
Protocol Biopsy
Indication Biopsy
Total
119
19
Normal
59
Acute tissue injury
35
25
10
Glomerulonephritis
21
a
IgA Nephropathy
12
b
Focal segmental glomerulosclerosis
c
Membranous glomerulonephritis
Viral Infection
Rejection
11
Others Pyelonephritis-1, TMA-1
Inadequate sample
IgA, Immunoglobulin A; TMA, thrombotic microangiopathy
Acute tubular injury. It was the most common finding (21.00%; N=25 in PB and 52.63%; N=10 in indication biopsy) in our biopsy cohorts.[Table 3]
Rejection. Rejection rates of our transplant population was 5.41%, demonstrated in 11 kidney biopsies among 203 total transplants. Surveillance biopsy detected rejection in 2.46% of total transplants done, or in 4.2% of patients undergoing PBs and contributed to detection of rejection in 45.45% of all rejections detected.
Glomerulonephritis. Glomerulonephritis (GN) was seen in 19 PBs.
Viral Infections. Of the total 7 BK polyomavirus associated nephropathy (BKPyV-nephropathy) cases, 85.71% were detected on PB.
Others. We didn’t find any reports of drug toxicities or other abnormal findings in the PBs done after 6 months of LDKT. There was one report each suggesting pyelonephritis and thrombotic microangiopathy.
Patient survival. There were no deaths within the first 12 months after transplantation
Surveillance allograft biopsies contribute significantly to the total rejections detected early after transplantation. Additionally, it also helps in detection of glomerulonephritis and BK virus nephropathy. PB at various time points are helpful in delineating the natural history of the graft and hence the long term outcomes of a transplant patient
