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Analysis of Mycophenolic Acid in saliva matrix in Renal Transplant patients

Investigating the Feasibility of Estimating Mycophenolic Acid from Saliva using High Performance Liquid Chromatography – Fluorescence Method for Determining Mycophenolate Exposure in Patients with Renal Transplantation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/077757
Enrollment
30
Registered
2024-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: NIL: NIL

Sponsors

Department of Pharmacology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult stable renal transplantation studies and patients with normal albumin range.

Exclusion criteria

Exclusion criteria: Patients with multi organ transplantation Pregnant or lactating women Patients with secondary infection or malignancy

Design outcomes

Primary

MeasureTime frame
Anticipated outcomes involve confirming the specificity and selectivity of the established High Performance Liquid Chromatography- fluorescence method for determining Mycophenolic Acid (MPA) concentrations in both saliva and plasma. The success of this method could position it as a reliable approach for Therapeutic Drug Monitoring (TDM) of MPA in diverse patient groups, irrespective of age.Timepoint: Before drug administration, 20 mins after drug administration followed at 1hr, 2hr, 4 hr , 6 hr , 8 hr and 12 hr—

Secondary

MeasureTime frame
correlation between plasma AUC and saliva AUC of MPA in Renal transplant patientsTimepoint: Before drug administration, 20 mins after drug administration followed at 1hr, 2hr, 4 hr , 6 hr , 8 hr and 12 hr—

Countries

India

Contacts

Public ContactProf Smita Pattanaik

PGIMER

bahaar279@gmail.com9872269171

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026