Evaluation of Interaction Between Immunosuppressive Drugs and Protein-bound Uremic Toxins in Renal Transplant Patients

NCT04963673 | Withdrawn

• 1 other identifier: PI2019_843_0060
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied to date. The investigator research hypothesis is that, due to the strong plasma protein binding of calcineurin inhibitors, an interaction with protein-bound uremic toxins could alter drug concentrations that explain difficulties in reaching therapeutic targets.

Conditions

Kidney Transplant; Immunosuppression; Uremic; Toxemia

Keywords

Kidney Transplant; Immunosuppression; Uremic; Toxemia

Outcome Measures

Primary Outcomes (2)

• plasma tacrolimus concentration without plasma uremic toxin adjustment

  at day 0

• plasma tacrolimus concentration with plasma uremic toxin adjustment

  at day 0

Secondary Outcomes (2)

• plasma ciclosporin concentration without plasma uremic toxin adjustment

  at day 0

• plasma ciclosporin concentration with plasma uremic toxin adjustment

  at day 0

Study Arms (2)

DFG> 40 ml / min

Kidney transplant population followed at CHU Amiens (group 1 ⇾ DFG\> 40 ml / min).

Other: calcineurin inhibitor dosage

DFG < 40 ml / min

Kidney transplant population followed at CHU Amiens (group 2 ⇾ DFG \< 40 ml / min).

Other: calcineurin inhibitor dosage

Interventions

calcineurin inhibitor dosage OTHER

The dosage of calcineurin inhibitors will be done as usual by the toxicology pharmacology laboratory of the CHU Amiens-Picardie. If the patient does not object, the determination of protein-bound uremic toxins from the rest of the collected blood tube will be performed using high performance liquid chromatography.

DFG < 40 ml / min; DFG> 40 ml / min

Eligibility Criteria

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

Study Population

Kidney transplant population followed at CHU Amiens (group 1 ⇾ DFG\> 40 ml / min, group 2 ⇾ DFG \< 40 ml / min).

You may qualify if:

• renal transplant patient followed at the University Hospital of Amiens and transplanted for over a year
• patient treated with a calcineurin inhibitor
• patient having a blood test for evaluation of calcineurin inhibitor concentrations by the toxicology pharmacology laboratory of the Amiens-Picardie University Hospital,
• patient affiliated with social security.

You may not qualify if:

• patient in phase of acute rejection of the graft,
• patient having opposed his participation,
• patient under guardianship or curatorship or deprived of public right

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Youssef Bennis, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Sandra Bodeau, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: July 6, 2021
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)