New Possibilities of TDM of Cyclosporine A and its metabolites after kidney transplantation

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004299-19-CZ

Enrollment

375

Registered

2005-10-07

Start date

2005-10-26

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

patient on standart immunusupresive therapy with cyclosporine A after renal transplantation

Interventions

Trade Name: not fixed in the protocol Pharmaceutical Form: INN or Proposed INN: CICLOSPORINUM CAS Number: 59865-13-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: renal transplant patients on standart therapy with cyclosporine A Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: end of treatment with cyclosporine A, disagreement of patients

Design outcomes

Primary

Measure	Time frame
Main Objective: The target of this project is to clarify the importance of TDM of CsA and its principal metabolites by LC-MS in lymphocytes when compared with currently used methods C through, AUC, and C2. ;Secondary Objective: We further wish for detection the role of the lipofile metabolite AM4N in imunosupresion and toxicity, and alternatively other metabolites analyzed by LC-MS.;Primary end point(s): to clarify the importance of TDM of CsA and its principal metabolites by LC-MS in lymphocytes when compared with currently used methods C through, AUC, and C2. We further wish for detection the role of the lipofile metabolite AM4N in imunosupresion and toxicity, and alternatively other metabolites analyzed by LC-MS. to find the therapeutic range for safety and effective therapy with CsA	—

Measure

Time frame

Main Objective: The target of this project is to clarify the importance of TDM of CsA and its principal metabolites by LC-MS in lymphocytes when compared with currently used methods C through, AUC, and C2. ;Secondary Objective: We further wish for detection the role of the lipofile metabolite AM4N in imunosupresion and toxicity, and alternatively other metabolites analyzed by LC-MS.;Primary end point(s): to clarify the importance of TDM of CsA and its principal metabolites by LC-MS in lymphocytes when compared with currently used methods C through, AUC, and C2. We further wish for detection the role of the lipofile metabolite AM4N in imunosupresion and toxicity, and alternatively other metabolites analyzed by LC-MS. to find the therapeutic range for safety and effective therapy with CsA

—

Countries

Czech Republic

Outcome results

None listed

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