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OPTIMIZATION OF MYCOPHENOLIC ACID TREATMENT IN RENAL TRANSPLANT RECIPIENTS

PLASMA LEVEL MONITORING OF MYCOPHENOLIC ACID IN RENAL TRANSPLANT RECIPIENTS

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2008/091/000250
Enrollment
25
Registered
2009-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Post renal transplant recipients after at least 3 weeks of renal transplantation

Interventions

Intervention1: blood sampling: No pharmacological intervention in the ongoing treatment as per local practice, only 2 mL blood samples for 3 times taken for plasma level estimation Control Interventio

Sponsors

DEPARTMENT OF PHARMACOLOGY AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients coming for follow up at Nephrology Outpatient Department at AIIMS, New Delhi, who were having renal transplantation for at least 3 weeks before, age between 20-60 years, belonging to either sex, receiving MMF or EC-MPS for a minimum period of 7 days with tacrolimus and steroid in the treatment regimen were candidates for inclusion in the study.

Exclusion criteria

Exclusion criteria: Patients not agreed for written informed consent, using any other immunosuppressant, insufficient address for follow-up, or unwillingness to return for follow-up were not admitted to the study.

Design outcomes

Primary

MeasureTime frame
Primary outcomeTimepoint: The primary endpoint was to correlate mycophenolic acid area under the concentration-time curve with acute graft dysfunction episodes and adverse drug events.

Secondary

MeasureTime frame
Secondary outcomeTimepoint: Additional analyses were done on the correlation of mycophenolic acid area under the concentration-time curve with patient reported outcomes, concomitant tacrolimus dosing, age, sex, MPA formulations.

Countries

India

Contacts

Public ContactProfessor Y K Gupta

Junior resident

scsarangi@gmail.com011-26593684

Outcome results

None listed

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