The Effects of Microbiota Composition on Immunosuppression Protocols in Transplantation

NCT04360031 | Unknown DMC FDA Drug

• 1 other identifier: Microbiota/TAC/MPA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Solid organ transplantation is the treatment of choice for patients suffering from end-stage organ disease, including for chronic kidney failure. The implementation of effective immunosuppressive therapies has already significantly improved the prognosis for graft survival. However, these therapies are often associated with considerable inter- and intra-individual variability both in terms of response or in terms of pharmacokinetics. Innovative approaches must be considered, such as studying the involvement of intestinal microbiota in the pharmacology of these drugs. The general aim of the study is therefore to relate the variabilities observed in the pharmacology (mainly pharmacokinetics) of immunosuppressive drugs used in renal transplantation (tacrolimus and mycophenolate mofetil) and the composition of the intestinal microbiota of renal transplant patients.

Conditions

Kidney Transplant; Complications; Immunosuppression; Transplant Failure

Keywords

Tacrolimus; Mycophenolate Mofetil; Transplantation; Kidney transplant; Calcineurin inhibitors

Outcome Measures

Primary Outcomes (1)

• Study of the links between immunosuppressive drugs pharmacology and intestinal microbiota composition

  The general aim of the study is to relate the variabilities observed in the pharmacology (mainly pharmacokinetics) of immunosuppressive drugs used in kidney transplantation (tacrolimus and mycophenolate mofetil) and the composition of the intestinal microbiota of these patients.

  24 months

Secondary Outcomes (9)

• Identify links between oral dosage and concentrations found in feces

  18 months

• Identify genetic factors underlying the links between microbiota and Tacrolimus/Mycophenolate Mofetil

  18 months

• Tacrolimus concentrations and microbiota

  18 months

• Tacrolimus concentrations and genetic polymorphisms

  18 months

• Tacrolimus concentration and demographics

  18 months

Study Arms (1)

Tacrolimus / Mycophenolate Mofetil

All patients receive maintenance immunosuppressive treatment of tacrolimus in combination with Mycophenolate Mofetil.

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

Tacrolimus and Mycophenolate Mofetil are given in accordance with patient's current regimen

Also known as: Mycophenolate Mofetil

Tacrolimus / Mycophenolate Mofetil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant patients followed at the Saint-Luc University Clinics and having been transplanted in the abdominal transplant service of the clinics will be recruited for the study.

You may qualify if:

• Patients within 1 to 8 years post transplantation
• Aged between 18 and 75 years old
• Patients receiving tacrolimus and mycophenolate mofetil as part of their immunosuppressive therapy
• French speaking
• BMI between 18 and 30.

You may not qualify if:

• Use of tobacco
• Potential Alcohol problems (less than two positive answers to the CAGE questionnaire)
• Use of antibiotic medication within 3 months of the sample collection
• Use of laxative medication within 2 weeks of the sample collection
• Use of anti-fungal medication within 2 weeks of the sample collection
• Pregnant or lactating patients.

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

• Degraeve AL, Bindels LB, Haufroid V, Moudio S, Boland L, Delongie KA, Dewulf JP, Eddour DC, Mourad M, Elens L. Tacrolimus Pharmacokinetics is Associated with Gut Microbiota Diversity in Kidney Transplant Patients: Results from a Pilot Cross-Sectional Study. Clin Pharmacol Ther. 2024 Jan;115(1):104-115. doi: 10.1002/cpt.3077. Epub 2023 Oct 30.

  PMID: 37846607 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

In all patients, blood and urine will be retained, Feces samples will be collected and retained(when possible),

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Vincent Haufroid, MD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MICHEL MOURAD, MD

CONTACT

003227642213; michel.mourad@uclouvain.be

Laure ELENS, PhD

CONTACT

003227647227; laure.elens@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: February 10, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)