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NCT04587141: RIDARTII
Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial
Phase 3 trial testing Sucrosomial iron in Iron Deficiency Anemia in 300 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 1 January 2020 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Sucrosomial iron — full drug profile →
- Ferric Gluconate
- Ferric carboxymaltose (FERRIC CARBOXYMALTOSE) — full drug profile →
Conditions studied
- Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Who can join
18 and older, any sex, with Iron Deficiency Anemia or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anemia is the most common extraintestinal manifestation of inflammatory bowel diseases (IBD), Although most cases of anemia in IBD are due to iron deficiency, many patients with iron deficiency anemia (IDA) are not treated with iron supplementation. In addition, it has not been firmly established which iron supplementation modality provides the best results in terms of effectiveness and safety. In the present study the investigators will compare the effectiveness and efficacy of three iron supplementation modalities in IBD-associated IDA. There will be two arms of parenteral (iv) iron supplementation (ferric carboxymaltose and ferric gluconate) and one arm of oral supplementation (sucrosomial iron). Primary objective of the study is is to compare the efficacy of oral iron with that of the iv iron supplementation regimens. The primary outcome is measured as the percentage of patients responsive to iron supplementation. Response is defined by Hb normalization or by an Hb increase ≥2 g/dL by week 8 from start of therapy. As secondary objectives the influence of anemia and its treatment on fatigue, quality of life, hospitalizations, additional outpatient visits, number of endoscopic examinations; further treatments and relative side effects will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04587141
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Related trials
Other trials of Sucrosomial iron
Trials testing the same drug.
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Other recruiting trials for Iron Deficiency Anemia
Currently open trials in the same condition.
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- NCT06012760 — The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion · NA · recruiting
- NCT06742528 — Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients · NA · recruiting
- NCT05929729 — Iron Deficiency Anemia (IDA) and the Brain · Phase 4 · recruiting
- NCT05985070 — Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults · NA · active not recruiting
Other Fondazione IRCCS Policlinico San Matteo di Pavia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04587141 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Policlinico San Matteo di Pavia
- Last refreshed: 19 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04587141.
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