Is NCT05179226 recruiting in Miami, FL?

Yes, NCT05179226 is currently recruiting participants at its Miami, FL location. This iron deficiency, anaemia in children clinical trial is actively enrolling qualified participants.

How do I join the iron deficiency, anaemia in children clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Iron Deficiency, Anaemia in Children Clinical Trial in Miami, FL

About This Iron Deficiency, Anaemia in Children Study in Miami

Several clinical trials have been reported for ferric derisomaltose where it has been shown to be well tolerated and to improve markers of IDA. All clinical trials with ferric derisomaltose have been performed in adults, however, IDA is not specific to the adult population. In fact, children are likely to develop IDA due to their rapid growth. The aim in this trial is to evaluate the efficacy and safety of intravenous (IV) ferric derisomaltose in children 0 to \<18 years of age with IDA due to NDD-CKD or with IDA who are intolerant or unresponsive to oral iron . The subjects will receive ferric derisomaltose/iron isomaltoside 1000 (Monoferric®/Monofer®), at single doses of 10 mg/kg or 20 mg/kg with a maximal dose of 1000 mg. 24 subjects will be part of a PK assessment, meaning that more blood samples will be drawn within the first week after treatment. The blood samples will be used for analysis of the amount of total iron in the blood from treatment is given to day 7. For the individual subject, duration of the trial will be approximately 10 weeks (including a 14-day screening period) and each subject will attend 6-9 visits. Subjects who will be included in the PK assessments will attend 8 (subjects age 6 to \<12 years old and 0 to \<6 years old) or 9 (subjects age 12 to \<18 years old) visits, while the other subjects will attend 6 visits.

Sponsor: Pharmacosmos A/S

Who Can Participate

Inclusion Criteria

Subjects \<18 years

Informed consent and child assent, as age-appropriate, obtained before any trial- related activities and willingness to participate. LAR of the subject must sign and date the ICF (according to local requirements). The child must sign and date the CAF or provide oral assent, if required according to local requirements

IDA caused by different etiologies such as gastrointestinal disease, NDD-CKD, or other conditions leading to IDA

Hb concentration less than the 5th percentile for age and sex-specific reference range (Appendix B)

Subjects with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b): a) Subjects with NDD-CKD:

TSAT ≤35 % or s-ferritin \<100 ng/mL

Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2

If on ESA, receiving stable ESA regimen defined as dose adjustments no more than ± 20 % for ≥8 weeks prior to screening b) Subjects with documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to trial enrolment.

TSAT ≤20 % or s-ferritin \<100 ng/mL

Exclusion Criteria

Anemia caused by factors other than IDA according to Investigator's judgment

S-ferritin \>600 ng/mL

Hb ≤5.0 g/dL

Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)

ALAT and/or ASAT \>2 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)

Pregnant or nursing female subjects. In order to avoid pregnancy, female subjects of childbearing potential have to use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) or be abstinent during the whole trial period and 7 days after the last dosing. Childbearing potential refers to all female subjects ≥12 years old or \<12 years old who have started menstruating

Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose

Received an investigational drug within 30 days prior to screening

Treatment with IV iron within 10 days prior to screening

Treatment with blood transfusion, radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 30 days prior to screening

Planned elective surgery (or planned surgery during the trial period) where significant blood loss is expected within the last 30 days prior to screening

Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)

Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT05179226) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Iron Deficiency, Anaemia in Children Treatment Options in Miami, FL

If you're searching for iron deficiency, anaemia in children treatment options in Miami, FL, this clinical trial (NCT05179226) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced iron deficiency, anaemia in children specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all iron deficiency, anaemia in children clinical trials near you to find additional studies recruiting in your area.

Iron Deficiency, Anaemia in Children Clinical Trial in Miami, FL

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