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Kidney Week

Abstract: FR-PO338

Clinical Context for RBC Transfusions in CKD Patients: Results of the START-CKD Trial

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Weir, Matthew R., University of Maryland School of Medicine, Baltimore, Maryland, United States
  • Berns, Jeffrey S., University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States
Background

Anemia is a common complication for patients with progressive CKD which untreated can lead to increased RBC transfusions (TX). Tx avoidance wherever possible is recommended in such patients to prevent the risk of allo-sensitization. Erythropoiesis-stimulating agents (ESA) have been used in CKD patients to reduce the need for Tx. The START-CKD trial evaluated an ESA treatment (darbepoetin) on the incidence of RBC Tx in anemic CKD subjects using either a hemoglobin (Hgb)-based titration algorithm (TD) or a fixed dose (FD). This study collected prospectively Tx data.

Methods

This was a US phase 3, multicenter, randomized, double-blind, parallel group study. 377 participants with stage 3-5 CKD were treated in the TD and in the FD arms for a period of up to 2 years. Tx, per protocol, were performed as deemed necessary by the treating physician and were prospectively adjudicated with the reasons and context for Tx recorded.

Results

The average age of the subjects, baseline Hgb and estimated GFR were balanced between the arms: 69 yrs, 9,0 g/dL and 22 ml/min//1.73m2. The primary endpoint of the study was similar between the TD and FD, 24% in both arms with an average Hgb at the time of first Tx of 7.4 vs 7.3 g/dL respectively. All Tx events are shown below:

Conclusion

The main reason for Tx was symptoms which were principally constitutional. Bleeding accounted for approximately 20% of Tx. The Hgb at the time of Tx was consistent with transfusion practice guidelines.

Primary Reason and ContextTDFD
Number TF events127141
Primary Reason – n (%)  
Acute trauma4 (3.1)1 (0.7)
Planned8 (6.3)14 (9.9)
Critical illness2 (1.6)5 (3.5)
Worsening SX66 (52.5)75 (53.2)
Worsening Anemia10 (7.90)2 (1.4)
   
Clinical Situation – n (%)  
Bleeding28 (22.0)27 (19.1)
Trauma3 (2.4)0 (0.0)
Surgery/procedure9 (7.1)14 (9.9)
GI hemorrhage15 (11.8)9 (6.4)
Symptom77 (60.6)89 (63.1)
Chest pain10 (7.9)2 (1.4)
Dyspnea35 (27.6)49 (34.8)
Constitutional50 (39.4)57 (40.4)

Funding

  • Commercial Support