NCT05114278

Brief Summary

The study aims is to evaluate the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery). This randomized multicenter trial compare the administration of intravenous iron by infusion (Ferinject©: 15 mg/kg in NaCl solution in 30 min) and oral iron in combination; to patients receive only oral iron as standard care. The first benefit with IV Iron supplementation is to correct iron deficiency more rapidly than oral iron alone because of trouble of absorption in case of intestinal villous atrophy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

4.2 years

First QC Date

September 9, 2021

Last Update Submit

January 17, 2022

Conditions

Celiac Disease

Keywords

Celiac diseaseIron deficiency

Outcome Measures

Primary Outcomes (1)

  • Total villous recovery

    The primary endpoint is the proportion of patients with total villous recovery (total remission) on the last duodenal biopsies. 6 formalin and 2 frozen duodenal biopsies will be performed. Intestinal mucosal assessment will be performed by a centralized histological analysis according to the Marsh classification. Readers will be blind to the treatment received.

    12 months

Secondary Outcomes (16)

  • Atrophic gastritis

    12 months

  • Partial recovery of intestinal villous atrophy

    12 months

  • Iron deficiency

    12 months

  • Anaemia

    12 months

  • Intraepithelial lymphocytes

    12 months

  • +11 more secondary outcomes

Study Arms (2)

Oral Iron + IV Ferinject

EXPERIMENTAL

Experimental group will receive intravenous iron infusion (Ferinject©: 15 mg/kg in NaCl solution IV) at randomization, 2weeks after randomization, 4weeks after randomization, and then every month for a total of one year.

Drug: FerinjectDrug: oral iron

Oral Iron only

ACTIVE COMPARATOR

Comparison group will not receive any intravenous treatment. Both experimental and comparison groups will receive an oral iron supplementation (100 mg/day).

Drug: oral iron

Interventions

FerinjectDRUG

Experimental group will receive intravenous iron infusion (Ferinject©: 15 mg/kg in NaCl solution IV) at randomization, 2weeks after randomization, 4weeks after randomization, and then every month for a total of one year. Comparison group will not receive any intravenous treatment. Both experimental and comparison groups will receive an oral iron supplementation (100 mg/day).

Also known as: Experimental arm
Oral Iron + IV Ferinject
oral ironDRUG

All patients will receive an oral iron supplementation (100mg/day).

Also known as: Control arm
Oral Iron + IV FerinjectOral Iron only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients free of mental illness, able to sign consent and \>18year
  • Celiac disease confirmed by presence of serum celiac antibodies and villous atrophy on intestinal biopsy before starting gluten free diet (GFD)
  • Intestinal villous atrophy on duodenal biopsy (performed within 1 month) showing villous atrophy
  • Patient under GFD or starting GFD with strict compliance
  • Hemoglobin level (Hb) \<12g/dL \& Hb\>8g/dL
  • Well tolerated anemia
  • Iron deficiency defined by: serum iron level \< 11 µmol/L, ferritinemia \< 20µg/L and/or transferrin saturation index \<0.2

You may not qualify if:

  • Patient not able to sign, mental illness, pregnancy
  • Complicated celiac disease: intestinal malignancies
  • Severe anemia (Hb \<8g/dL) and/or poorly tolerated anemia requiring systematic iron IV supplementation or blood transfusion
  • Serious severe disease having short-term prognostic implication
  • Contraindication to intravenous iron infusion: known drug allergy
  • Pregnant or breastfeeding women
  • Participation in another interventional trial
  • Patients treated by steroids, immunosuppressors or chemotherapy drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Celiac DiseaseIron Deficiencies

Interventions

ferric carboxymaltoseIron

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism Disorders

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Georgia MALAMUT, MD, PhD

    Cochin, AP-HP, Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine GOUDE-ORY, MSc

CONTACT

+33144841722karine.goude@aphp.fr

Sabrina BOUDIF, MSc

CONTACT

+33156095976sabrina.boudif@aphp.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Upper endoscopy with duodenal biopsy will be performed at most one month before randomization, and one month after the last infusion (experimental group) and between the 12th and the 13h month after randomization (control group). Histological analysis (villous recovery, primary endpoint) will be centrally performed by an expert pathologist blind to the group of treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase IV, open, randomized, 2-arms parallel controlled trial with blinded assessment of end-point.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

November 9, 2021

Study Start

February 15, 2022

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(1)