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Drug levels of Mycophenolic acid and the genetic mutations that affects these blood levels in patients with autoimmune diseases taking durg mycophenolate mofetil (MMF)

Population pharmacokinetics and pharmacogenetics of mycophenolic acid in Indian patients with autoimmune disorders receiving Mycophenolate Mofetil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/050985
Enrollment
100
Registered
2023-03-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

Seth GS Medical College and KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults of any gender aged 18 years and above, willing to provide a written informed consent 2. Patients who are on MMF for at least 5 days 3. Willing to follow the study protocol

Exclusion criteria

Exclusion criteria: 1. Patients who are critically ill 2. Women who are pregnant or breast feeding 3. Any other reason that in the opinion of the investigator is likely to cause harm to the participant or will adversely affect the results of the study

Design outcomes

Primary

MeasureTime frame
Serum Mycophenolic acid concentrationsTimepoint: Day 0 (Baseline)—

Secondary

MeasureTime frame
Pharmacogenetics of UGT1A9, UGT2B7, SLCO1B1, SLCO1B3, IMPDH1, and IMPDH2 genesTimepoint: Day 0 (Baseline)—

Countries

India

Contacts

Public ContactDr Jeffrey Pradeep Raj

Seth GS Medical College & KEM Hospital

jpraj.m07@gmail.com7904286189

Outcome results

None listed

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