CLINICAL TRIALS PROFILE FOR MIRCERA

All Clinical Trials for MIRCERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00048035 ↗	A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia	Completed	Hoffmann-La Roche	Phase 2	2002-03-01	This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
NCT00048048 ↗	A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.	Completed	Hoffmann-La Roche	Phase 2	2002-03-01	This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
NCT00077597 ↗	A Study of Mircera for the Treatment of Anemia in Dialysis Patients	Completed	Hoffmann-La Roche	Phase 3	2004-02-01	This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
NCT00077610 ↗	A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients	Completed	Hoffmann-La Roche	Phase 3	2004-02-01	This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
NCT00077623 ↗	A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.	Completed	Hoffmann-La Roche	Phase 3	2004-03-01	This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
NCT00077766 ↗	A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.	Completed	Hoffmann-La Roche	Phase 3	2004-03-01	This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
NCT00081471 ↗	A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis	Completed	Hoffmann-La Roche	Phase 3	2004-06-01	This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Clinical Trial Conditions for MIRCERA

Condition Name

Condition Name for MIRCERA
Intervention	Trials
Anemia	58
Kidney Disease, Chronic	3
Renal Anemia	2
Renal Anemia of Chronic Kidney Disease	2

Condition MeSH

Condition MeSH for MIRCERA
Intervention	Trials
Anemia	57
Renal Insufficiency, Chronic	26
Kidney Diseases	26
Kidney Failure, Chronic	4

Clinical Trial Locations for MIRCERA

Trials by Country

Trials by Country for MIRCERA
Location	Trials
United States	264
Canada	39
Spain	31
Italy	28
Germany	21

Trials by US State

Trials by US State for MIRCERA
Location	Trials
California	16
Michigan	14
Texas	12
Ohio	12
New York	12

Clinical Trial Progress for MIRCERA

Clinical Trial Phase

Clinical Trial Phase for MIRCERA
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	41
Phase 2	9

Clinical Trial Status

Clinical Trial Status for MIRCERA
Clinical Trial Phase	Trials
Completed	63
Terminated	7
Not yet recruiting	2

Clinical Trial Sponsors for MIRCERA

Sponsor Name

Sponsor Name for MIRCERA
Sponsor	Trials
Hoffmann-La Roche	66
AstraZeneca	1
FibroGen	1

Sponsor Type

Sponsor Type for MIRCERA
Sponsor	Trials
Industry	75
Other	5

MIRCERA Market Analysis and Financial Projection

MIRCERA: Clinical Trials, Market Analysis, and Projections

Introduction to MIRCERA

MIRCERA, or methoxy polyethylene glycol-epoetin beta, is a long-acting erythropoiesis-stimulating agent (ESA) used to treat anemia associated with chronic kidney disease (CKD) and, in some cases, chemotherapy-induced anemia. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Adult Studies

MIRCERA has been extensively studied in adults with anemia associated with CKD. Six main studies involving 2,399 adults compared MIRCERA with other ESAs like epoetin alfa or beta and darbepoetin alfa. These studies showed that MIRCERA is as effective as comparator medicines in correcting and maintaining haemoglobin levels.

• In patients starting treatment for anemia, MIRCERA was administered either intravenously every two weeks or subcutaneously every two weeks. The results indicated significant increases in haemoglobin levels, with 93% to 98% of patients achieving the desired haemoglobin levels[1][4].
• For patients already receiving ESA treatment, switching to MIRCERA maintained haemoglobin levels effectively over 36 weeks, with no overall change in haemoglobin levels compared to existing treatments[1].

Pediatric Studies

MIRCERA has also been studied in pediatric patients (ages 5-17 years) with CKD who were on hemodialysis and had stable haemoglobin levels while previously receiving another ESA. These studies demonstrated that MIRCERA, administered intravenously every four weeks, maintained haemoglobin levels within the recommended range of 10 to 12 g/dL. After 20 weeks, 81% of patients maintained haemoglobin levels within this range, and in 75%, haemoglobin levels did not increase or decrease by more than 1 g/dL[1][4].

Market Analysis

Current Market Size and Growth

As of 2023, the global MIRCERA market is valued at approximately USD 1.2 billion. The market is projected to grow at a compound annual growth rate (CAGR) of 5.4% from 2024 to 2030[3].

Regional Market Performance

• North America: This region is a significant player in the global MIRCERA market, driven by the United States and Canada. The robust economy, technological advancements, and strong consumer base contribute to its dominance[3].
• Europe: Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries like the UK, Germany, France, and Italy are key contributors[3].
• Asia-Pacific: This region is rapidly growing, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization are driving the demand for MIRCERA[3].

Market Trends and Drivers

The MIRCERA market is driven by several key trends:

• Increasing Prevalence of CKD and Cancer: The growing demand for long-acting ESAs, particularly in patients undergoing dialysis, is a significant driver. MIRCERA's extended dosing intervals make it an attractive option for both patients and healthcare providers, improving patient adherence and reducing healthcare burdens[3].
• Advantages Over Traditional ESAs: MIRCERA offers less frequent administration compared to traditional ESAs, which enhances patient compliance and reduces the burden on healthcare systems[3].

Market Projections

Forecasted Growth

The global MIRCERA market is anticipated to continue its steady growth, driven by the increasing prevalence of CKD and cancer, as well as the growing awareness of anemia management. By 2030, the market is expected to reach a valuation significantly higher than its current level, driven by a CAGR of 5.4% from 2024 to 2030[3].

Regional Growth

• North America and Europe: These regions are expected to maintain their dominance due to their robust healthcare systems and high purchasing power.
• Asia-Pacific: This region is projected to experience rapid growth due to its large population and increasing healthcare expenditure[3].

Key Players and Market Competition

The MIRCERA market includes several key players known for their strengths in the pharmaceutical industry. While the specific names of these companies are not detailed in the available sources, it is clear that competition in this market is driven by the quality of the product, dosing convenience, and overall patient outcomes[3].

Safety and Adverse Reactions

MIRCERA has a safety profile that includes serious adverse reactions such as increased mortality, myocardial infarction, stroke, and thromboembolism. Other notable adverse reactions include hypertension, seizures, pure red cell aplasia (PRCA), and severe allergic reactions. The most commonly reported adverse reactions in clinical trials were hypertension, diarrhea, and nasopharyngitis[4].

Conclusion

MIRCERA is a significant player in the treatment of anemia associated with CKD, offering a long-acting alternative to traditional ESAs. Its efficacy in both adult and pediatric patients, combined with its convenient dosing regimen, positions it for continued growth in the global market.

Key Takeaways

• Efficacy: MIRCERA is as effective as other ESAs in correcting and maintaining haemoglobin levels in patients with CKD.
• Market Size: The global MIRCERA market was valued at approximately USD 1.2 billion as of 2023.
• Growth Rate: The market is projected to grow at a CAGR of 5.4% from 2024 to 2030.
• Regional Performance: North America, Europe, and the Asia-Pacific region are key markets.
• Safety Profile: MIRCERA has a manageable safety profile but includes serious adverse reactions.

Frequently Asked Questions (FAQs)

What is MIRCERA used for?

MIRCERA is used to treat anemia associated with chronic kidney disease (CKD) in adult and pediatric patients on hemodialysis, as well as in adult patients not on dialysis[1][4].

How is MIRCERA administered?

MIRCERA can be administered intravenously or subcutaneously, with dosing intervals of every two weeks in adults and every four weeks in pediatric patients[1][4].

What are the benefits of MIRCERA over traditional ESAs?

MIRCERA offers less frequent administration, which improves patient compliance and reduces the burden on healthcare systems[3].

What are the common adverse reactions associated with MIRCERA?

Common adverse reactions include hypertension, diarrhea, and nasopharyngitis. Serious adverse reactions can include increased mortality, myocardial infarction, stroke, and thromboembolism[4].

What is the projected growth rate of the MIRCERA market?

The global MIRCERA market is projected to grow at a CAGR of 5.4% from 2024 to 2030[3].

Cited Sources

1. European Medicines Agency - Mircera | European Medicines Agency (EMA)
2. Cognitive Market Research - Mircera methoxy polyethylene glycol epoetin beta Market Report
3. OpenPR - Mircera (methoxy polyethylene glycol-epoetin beta) Market
4. MIRCERA Monograph - MIRCERA® (methoxy polyethylene glycol-epoetin beta) Injection