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Effect of Ferric Carboxymaltose in population lacking iron in real-liffe scenario.

PrescRiption Event MOnitoring for Ferric CarboxyMaltose in Management of Anemia in Indian Real Life ScEnario. (PROMISE) - PROMISE

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/12/039065
Enrollment
2000
Registered
2021-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Injection Ferric Carboxymaltose: Dose: Cumulative dose for repletion of iron using ferric carboxymaltose (FCM) is determined based on the patients body weight and hemoglobin (Hb) level

Sponsors

Emcure Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with iron deficiency anemia who received Ferric carboxymaltose injection (Orofer FCM) 500/1000 mg in clinical practice as per the locally approved prescribing information and treating physician is ready to share anonymized data of such patients, will be included. 2. Data for hematological parameters (hemoglobin, serum ferritin) are available at baseline and/or for minimum at 4 �± 1 weeks.

Exclusion criteria

Exclusion criteria: 1. Any other type of anemia apart from iron deficiency anemia. 2. Severe iron deficiency anemia with hemoglobin 3. Evidence of iron overload conditions (e.g. hemochromatosis/hemosiderosis). 4. Any malignancy. 5. Any condition that, in the opinion of the investigator, does not justify the patientââ?¬•s inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Adverse events occurring FCM infusionTimepoint: Till 4 weeks after FCM infusion

Secondary

MeasureTime frame
Change in hematological parameters like hemoglobin, serum ferritin, etc.Timepoint: At baseline and week 4

Countries

India

Contacts

Public ContactDr Onkar Swami

Emcure Pharmaceuticals Ltd

Onkar.Swami@emcure.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026