TABLE 1.

RCTs in kidney transplantation with renal function as primary endpoint, published after 2014 (14, 15, 23–30).

Study	Population	Intervention/control	Duration	Renal endpoint	Finding	Comments
APOLLO (23)	N = 93; >6 months after Tx sCr <2.5 mg/dl	I: conversion from CNI to EVR	12 months	eGFR: Nankivell	NSD	Premature termination due to slow recruitment. Higher eGFR — MDRD in EVR group
APOLLO (23)	N = 93; >6 months after Tx sCr <2.5 mg/dl	C: continuation of CNI	12 months	eGFR: Nankivell	NSD
CENTRAL (14)	N = 212; 7 weeks after Tx	I: conversion from CsA to EVR	3 years	Change in measured GFR by iohexol or⁵¹Cr-EDTA clearance from randomization to 36 months	NSD	High rate of study withdrawals. Benefit in renal function in EVR group in on-treatment analysis
CENTRAL (14)	N = 212; 7 weeks after Tx	C: continuation of CsA	3 years		NSD
SPIESSER(24)	N = 145; dnTx	I: SRL	12 months	eGFR: Nankivell	NSD	Benefit in renal function in EVR group in on-treatment analysis
SPIESSER(24)	N = 145; dnTx	C: CsA	12 months	eGFR: Nankivell	NSD
Tedesco-Silva et al. (25)	N = 256; 90–150 days after Tx	I: conversion from TAC to SRL	24 months	eGFR: MDRD change >5 ml/1.73 m² in on-therapy population (n = 195)	NSD	High discontinuation rate in SLR group
Tedesco-Silva et al. (25)	N = 256; 90–150 days after Tx	C: continuation of TAC	24 months		NSD	High discontinuation rate in SLR group
Knoll et al. (26)	N = 212; >3 months after Tx; eGFR ≥20 ml/min/1.73 m² and proteinuria ≥0.2 g/d	I: ramipril	48 months	Composite endpoint: doubling of sCr, ESRD, or death	NSD	Small numbers per group
Knoll et al. (26)		C: placebo	48 months	Composite endpoint: doubling of sCr, ESRD, or death	NSD	Small numbers per group
ELEVATE (27)	N = 715; 10–14 weeks after Tx	I: conversion from CNI to EVR	24 months	Change in eGFR — MDRD from randomization to 12 m	NSD	Significantly higher eGFR in EVR group vs CsA subgroup
ELEVATE (27)	N = 715; 10–14 weeks after Tx	C: continuation of CNI	24 months	Change in eGFR — MDRD from randomization to 12 m	NSD	Significantly higher eGFR in EVR group vs CsA subgroup
ADHERE (15)	N = 730; 28 days after Tx	I: TAC (8–12 ng/ml until Day 41 and then 6–10 ng/ml) + SRL	12 months	mGFR by iohexol clearance	NSD	High withdrawal rate in the intervention group
ADHERE (15)	N = 730; 28 days after Tx	C: continuation of TAC (8–12 ng/ml) + MMF	12 months	mGFR by iohexol clearance	NSD	High withdrawal rate in the intervention group
3C STUDY (28)	N = 394; 6 m after Tx	I: conversion from TAC to SRL	18 months	eGFR—MDRD	NSD	Significantly better renal function in SRL group in on-treatment analysis
3C STUDY (28)	N = 394; 6 m after Tx	C: continuation of TAC	18 months	eGFR—MDRD	NSD
BORTEJECT (29)	N = 44; presence of DSA and morphologic features of AMR ≥180 days after Tx, eGFR >20 ml/min/1.73 m²	I: bortezomib	24 months	Slope of eGFR—Mayo equation	NSD	Small sample size
BORTEJECT (29)		C: placebo	24 months	Slope of eGFR—Mayo equation	NSD	Small sample size
TRANSFORM (30)	N = 2037; dnTx	I: EVR + reduced-dose CNI	24 months	Composite of treated BPAR or eGFR—MDRD <50 ml/min/1.73 m² at 12 months	NSD	No difference in eGFR
TRANSFORM (30)	N = 2037; dnTx	C: MPA + standard-dose CNI	24 months		NSD	No difference in eGFR

AMR, antibody-mediated rejection; C, control group; CNI, calcineurin inhibitor; CsA, cyclosporine; dn, de novo; DSA, donor-specific antibodies; e, estimated; ESRD, end-stage renal disease; EVR, everolimus; GFR, estimated glomerular filtration rate; I, intervention group; m, measured; MDRD, Modification of Diet in Renal Disease; MPA, mycophenolic acid; NSD, no statistical difference; sCR, serum creatinine; SRL, sirolimus; TAC, tacrolimus; Tx, transplantation.