Date of publication: July 6, 2016

News & Views

ERA-EDTA 2016: Latest Insights on the Safety of IV Iron Therapy

The 53rd ERA-EDTA Congress was held in Vienna this year, with an extensive program covering a range of topics relevant to its international nephrology audience. This summary provides highlights of the sessions on iron deficiency anemia in CKD patients.

FIND-CKD study: The latest safety data

Dr Simon Roger presented 1-year safety data from the FIND-CKD study in an oral presentation.[1] FIND-CKD was a 56-week randomized controlled trial of intravenous ferric carboxymaltose (FCM) for the treatment of anemia in non-dialysis dependent CKD patients not receiving ESA therapy. Patients received ferric carboxymaltose to achieve either a higher or lower ferritin target, or received oral iron. Treating to the higher ferritin target of 400-600 µg/L resulted in more patients achieving and maintaining Hb >10 g/dL, or not requiring further treatment, than with oral iron.[2]

Additional analysis of the one-year study showed that the correction of iron deficiency anemia with IV FCM was well-tolerated:

n High ferritin FCM Low ferritin FCM Oral iron
Any AE per 100 patient years 91 100 105
Any SAE per 100 patient years 28 28 24

The incidences of infections or cardiac disorders were also similar between study groups. Adverse events were more often suspected to be related to study drug in patients receiving oral iron than in either of the FCM groups, with no SAEs reported as related to FCM. Renal function, as measured by eGFR, also remained stable across the groups and was unaffected by ferritin achieved or higher FCM doses.

In high-ferritin-target FCM patients who experienced serum ferritin ≥800ng/mL at least once, the incidence of any AE (80.5%) was not higher than the overall cohort (81.8%), and was similar to those patients in the oral iron and low-ferritin-target FCM whose ferritin never exceeded 200ng/mL (85.4%).

During the question and answer session on the presentation, Dr Roger also discussed that the investigators had not seen any safety concerns regarding cumulative dosing with IV FCM or from hospitalization data.

High serum ferritin and mortality due to inflammation not iron therapy

Dr Angelo Karaboyas presented results of an analysis of DOPPS and EURODOPPS data that assessed the association of serum ferritin levels with adverse outcomes in hemodialysis patients, following adjustment for multiple factors, including inflammation.[3]

Dr Karaboyas and his team developed four adjustment models:

  • Case-mix only
  • Case-mix and anemia management
  • Case-mix, nutrition, inflammation and hospitalizations
  • Case-mix and inflammation as measured by C-reactive protein (only routinely measured in Europe)

The highest one-year mortality risk was experienced by patients who had high serum ferritin levels (≥1200ng/mL in the US and ≥800ng/mL in Europe), levels at which IV iron is rarely used. The association between high serum ferritin and mortality was attenuated when adjusted for nutritional and inflammatory markers (particularly by C-reactive protein in Europe), suggesting that the association may be largely due to inflammation rather than anemia treatment.

CKDopps: Anemia prevalence and management varies significantly between countries

Dr Michelle Wong presented CKDopps data from Brazil, France, Germany and the US, examining anemia prevalence and its management in 5,695 non-dialysis CKD patients.

The CKDopps analysis highlighted the disparity in anemia and iron management between countries. In patients with Hb <11 g/dL, treatment with iron or ESA was more common in Brazil (61%) and Germany (66%) than France (49%) and the US (43%). Depending on the country, ferritin or TSAT levels were measured in 44% – 67% of patients receiving ESAs or iron therapy, and in 33% – 49% of those not receiving such therapies.

Future analyses by the CKDopps team will assess associations between patient characteristics and anemia management, as well as between anemia management and clinical & patient-reported outcomes.[4]

Additional highlights from ERA-EDTA 2016

Further highlights from presentations on iron deficiency anemia at the ERA-EDTA 2016 Congress include:

  • An assessment of the appropriateness of the new NICE guidelines for determining the presence of iron deficiency; results suggested that the percentage of hypochromic red cells (%HRC) and the reticulocyte Hb content or equivalent (Ret-He) are “useful tests” to determine the optimum treatment approach “where conventional tests such as ferritin may question the use of IV iron.”[5]
  • An analysis based on the FIND-CKD trial suggested that a model incorporating baseline Hb, ferritin, TSAT, diabetic status and gender is able to predict non-response to oral iron in ND-CKD patients with good sensitivity but weaker specificity. [6]

References

  1. Roger S, Bock AH, Carrera F, et al. SO035 – The Safety of Intravenous Ferric Carboxymaltose in Patients with Non-Dialysis Dependent CKD: 1-Year Results from the FIND-CKD Trial. Nephrol Dial Transplant. 2016;31(suppl 1):i15-i16. doi:10.1093/ndt/gfw123.03.
  2. Macdougall IC, Bock A, Carrera F, et al. The FIND-CKD study—a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale. Nephrol Dial Transplant. 2014;29(4):843-850. doi:10.1093/ndt/gft424.
  3. Karaboyas A, Zee J, Morgenstern H, et al. SO034 – Association Between Serum Ferritin and Mortality: US and EURODOPPS Findings. Nephrol Dial Transplant. 2016;31(suppl 1):i15-i15. doi:10.1093/ndt/gfw123.02.
  4. Wong MMY, Tu C, Zepel L, et al. SO037 – Anemia Prevalence and Treatment Among Patients with Chronic Kidney Disease Stage 3-5: Data from the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps). Nephrol Dial Transplant. 2016;31(suppl 1):i16-i17. doi:10.1093/ndt/gfw123.05.
  5. Brown C, Brown K, Jackson D, et al. SO038 – New Nice Guidance: Tests for Iron Deficiency – Friend or Foe? Nephrol Dial Transplant. 2016;31(suppl 1):i17-i17. doi:10.1093/ndt/gfw123.06.
  6. Macdougall I, Bock AH, Carrera F, et al. SP311 – A Model to Predict Haematopoietic Non-Response to Oral Iron in Patients with Non-Dialysis Dependent CKD: An Analysis from the FIND-CKD Trial. Nephrol Dial Transplant. 2016;31(suppl 1):i193-i194. doi:10.1093/ndt/gfw166.03.

Leave a Reply

Login

You are about to leave Compact-Renal.com

Clicking the "Continue" link below will take you to an external website. Compact Renal is not responsible for the contents of any external website. Compact Renal is providing these links to you as a convenience, and the inclusion of any links does not imply endorsement of the linked site by Compact Renal.

Do you wish to continue?

Continue Cancel