The Future of Renal Anemia Management: Opportunities & Challenges

Anemia is the most common complication of chronic kidney disease (CKD), associated with heart failure and left ventricular dysfunction in addition to a reduction in exercise capacity and quality of life. Although Erythropoiesis Stimulating Agents (ESA) and iron therapies have led to the improvement in patients suffering from anemia of CKD, new therapies are under study to fast and effective treatment of anemia of CKD. Moreover, some randomized controlled trials have also found using ESA to target normal hemoglobin function can be harmful. The only benefit of ESA therapy is avoidance of the blood transfusions. This is also leading to the advancement in the treatment of anemia of CKD without causing any harmful effects. According to the National Kidney Foundation, 10% population globally is affected by CKD, this, in turn, has increased in the number of patients for renal anemia treatment.

Anemia of CKD- New Therapies Changing Old Paradigms

A series of clinical trials have demonstrated serious safety problems of ESA, however, it has been found that high pharmacologic doses of ESA, instead of the rise in hemoglobin may reduce or mediate the harm. Hypoxia-Inducible Factor (HIF) are the proteins playing vital role in single transduction resulting in EPO production (higher levels of EPO are required in patients with CKD). These HIF activators have found to stimulate endogenous erythropoietin production while enhancing availability of iron. Some initial clinical trials also found these oral agents to replace ESA therapy while minimizing need for iron therapy for CKD related anemia along with other potential advantages.

There has been significant progress in the development of artificial blood in recent years with RCB production from hematopoietic stem cells as the key focus area regenerative therapy. In case of renal anemia or chronic kidney disease and anemic condition, the recombinant erythropoietin stimulating agent therapy proved to be prominent. However, with neoplastic and thrombotic complications, blood transfusion remains the only option.

More researchers and doctors are focusing on stem cell therapy for treatment of anemia. In this, cord blood, holding most adaptable stem cells is becoming a highly preferred therapy for anemia. While the cord blood stem cells are still under research, one of the distinct advantage of cord blood stem cell over bone marrow transplant is that the cord blood stem cell don’t need the exact match. Moreover, patients using umbilical cord cells have more treatment options.

In recent years, significant progress has been made to advance stem cell products as part of potential therapies for kidney diseases. Moreover, both preclinical studies and clinical trials of stem cells used for the treatment of kidney disease are rapidly increasing. Although preclinical reports support the application of stem cells in treatment of various renal diseases, no scalable, effective, and safe therapy has yet emerged from this preclinical research effort.

Meanwhile, an emerging approach for treating EPO deficiency for anemia treatment in patients with Kidney disease is the use of agents that can help to stimulate the production of endogenous EPO in both renal and non-renal tissues. This strategy might help to reduce adverse effect by producing more consistent level of EPO. With the increasing prevalence of anemia associated with CKD in children, new agents to enhance production of EPO is being focused on. For instance, in 2018, the US Food and Drug Administration (FDA) approved methoxy polyethylene glycol-epoetin beta an ESA to treat anemia in CKD in pediatric patients. 

Apart from ESA therapy, novel forms of oral iron products are also being developed with higher amount of iron to be absorbed by the gastrointestinal tract. Synergizing experimental efforts of different research groups by making the data comparable from lab to lab is likely to help speed up the research on new therapies for renal anemia management.

Challenges Associated with Renal Anemia Management

The current treatment options for renal anemia management are limited. There have been various clinical trials in both chronic kidney disease and end-stage renal disease demonstrating use of ESA to raise hemoglobin levels, however, no change has been seen in clinical outcomes including cardiovascular disease, fatal or non-fatal myocardial infraction, stroke or heart failure. Moreover, studies have also shown long term use of ESAs associated with higher risk of various cardiovascular disease and risk of seizures. Therefore, the majority of the side-effects related to the use of ESA are hindering the growth of renal anemia management.

Lack of awareness regarding anemia associated with CKD is also one of the challenges hampering renal anemia management. Moreover, delay in interventions and diagnosis is resulting in the progression of renal anemia.

Pregnancy is associated with many physiological changes in the renal system. With chronic kidney disease on rise along with anemia. Not all the kidney diseases during pregnancy manifest with proteinuria and hypertension, which are usually considered common. Many symptoms and signs are being overlooked in pregnancy, thus, emerging as the challenge in renal anemia management, especially during pregnancy. Moreover, sign and symptoms of chronic kidney disease and Pre-Eclampsia (PE) may overlap, this calls for the need of establishing systematic procedure while considering differential diagnosis between PE and CKD during pregnancy.

On the other hand, the drugs available for renal anemia treatment are expensive, thus resulting in higher out-of-pocket expenditure for patients. High cost of renal anemia treatment has emerged as one of the biggest challenges limiting the rate of patients seeking treatment with biologics, thereby, impacting the renal anemia management.

Although CKD associated anemia is treated with ESA and iron, recent trends have led to the wide application of intravenous iron while reducing the ESA doses leading to adverse effects on health. Dosing of iron has increased in recent years, while ESA dosing is decreasing. Moreover, high cost of ESA compared to relative affordability of iron is also contributing to the increasing adoption and dependency on IV iron.

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Clinical practices guidelines recommend the use of iron therapy in managing renal anemia. However, there is the need to adapt to the guidelines to meet specific need of the patients, as excessive iron dose may cause potential harm. 

Published by Shambhu

Shambhu Nath Jha with an experience nearing a decade has helped over 50 large and medium to small business enterprise to foray into new markets, increase footprint in the existing bucket and understand the nature of the beast. These beasts are the companies that have been primarily engaged in chemicals, material or packaging activities, and encountering challenge either in maintain P&L or staying ahead of their competitors. He has authored over 300 industry research papers consisting critical information such as market growth, total addressable market, serviceable addressable market, market size, forecast, player strategies, market share estimates and winning imperatives along with recommendations. He is also the pioneer of “three slope distributor/off-taker evaluation model” used by several multinational companies to track the performance of channel partners. A consultant by profession, writer by mood and explorer by desire, Shambhu Nath is currently employed with a London based market research and consulting firm as a full time consultant. A few of the industry verticals where he demonstrated his skill includes water and wastewater treatment chemicals, high purity alumina, water purifiers, activated carbon, chloramine filters, bio-based bioplastics, water purifiers, textile chemicals etc.

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