Transplant Trial Watch

The effect of maintaining high hemoglobin levels on long-term kidney function in kidney transplant recipients: a randomized controlled trial.

Tsujita, M., Kosugi, T. et al.

Nephrol Dial Transplant, 2018;[record in progress].


Aims
To determine the effect of low and high Hb target levels on kidney function of kidney transplant recipients.

Interventions
Patients were randomized into a high Hb group (n=64) and a low Hb group (n=63).

Participants
127 enrolled patients (20-70 years of age; KTx performed within the last 12 months; stable kidney function for preceeding 3 months prior to registration; Hb levels 9.0-11.5 g/dL).

Outcomes
The primary endpoint was the difference in the rate of decline of Cr-based eGFR (eGFRcre) between the initiation point and the 36-month follow-up assessment. Secondary outcomes measured the number of patients who progressed to end-stage renal disease (ESRD), occurrence of AR and cardiovascular events during the follow-up period.

Follow-up
Up to 36 months

CET Conclusions
The randomised controlled trial tested the hypothesis that sustained maintenance of target haemoglobin concentrations at high target levels (12.5-13.5 g/dL) with erythropoiesis-stimulating agents would limit deterioration of kidney function compared with low target levels (10.5-11.5 g/dL) in kidney transplant recipients. The randomisation order was computer-generated but there was no description of concealed allocation. The power calculation showed that a total of 100 patients were needed for a power of 80% with a significance level of 5%. The study randomised 127 patients of which 19 patients were excluded. The per-protocol analysis of the primary outcome (the difference in the rate of decline of creatinine-based eGFR between baseline and 36 months posttransplant) showed a significantly greater decline in eGFR for the low target group versus the high target group (-5.1±9.5 versus -1.0±8.4 mL/min/1.73m2).

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
University Hospital Medical Information Network - UMIN 000009594

Funding source
Non-industry funded