Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant

Renal Transplantation Clinical Trial

Official title:

Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00148252
• Other study ID #: NILS 02-08144
• Status: Terminated
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: June 6, 2012
• Start date: February 2003
• Est. completion date: February 2007

Study information

• Verified date: June 2012
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy

Description:

To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy.

Secondly to examine safety following withdrawal of CsA or MMF, respectively, by the following parameters:

• Biopsy verified acute rejection episodes, time to first rejection and number of steroid resistant rejection episodes within 12 months.

• Hematology (Hb, WBC, platelets) abnormalities within 12 months.

• Graft and patient survival at 12 months and 5 years. Absolute difference in renal function between withdrawal groups at 12 months. Three monthly changes in renal function from drug withdrawal to 12 months. Change in dyslipidemia frequency from drug withdrawal to 12 months. Change in hypertension frequency from drug withdrawal to 12 months. Change in glucose tolerance from drug withdrawal to 12 months. Cumulative incidence of clinical infections resulting in hospitalization within 12 months.

Sub protocols will also examine the following aspects:

Cardiovascular: Homocysteine. Lipid peroxidation. Microvascular function and vasoactive parameters Quality of life (QoL): ESRD SCL-TM, SF-36 (short version) and EQ-5D (GI-checklist extended) questionnaires will be used.

Pharmacoeconomical evaluation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 298
• Est. completion date: February 2007
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).

4. Kidney (only) transplant recipients with stable renal function (S-creatinine < 300 umol/L and an average increase in S-creatinine < 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.

5. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.

Exclusion Criteria:

• 1. PRA positivity > 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.

3. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Mycophenolate mofetil withdrawal

• Cyclosporione A withdrawal

Locations

Country	Name	City	State
Norway	Haukeland sykehus	Bergen
Norway	Lillehammer hospital	Lillehammer
Norway	Akershus Hospital	Nordbyhagen
Norway	Rikshospitalet, Section of Nephrology	Oslo
Norway	Ullevål hospital	Oslo
Norway	Hospital Telemark	Skien
Norway	Sentralsykehuset i Rogaland	Stavanger
Norway	Tromsø hospital	Tromsø
Norway	St. Olavs hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
Secondary	Graft and patient survival at 12 months and 5 years posttransplant.
Secondary	Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episodes within 12 months.
Secondary	Incidence of HB, WBC, platelet abnormal values requiring clinical intervention within 12 months.
Secondary	Incidence of need for additional immunosuppressive therapy at 12 months.
Secondary	Absolute difference in renal function between treatment groups at 12 months, evaluated by Nankivell`s formula (B).
Secondary	Renal function (Nankivell`s formula B) development over time (3 monthly) between treatment groups within 12 months.
Secondary	Change in dyslipidemia frequency from drug withdrawal to 12 months.
Secondary	Change in hypertension frequency from drug withdrawal to 12 months.
Secondary	Change in glucose tolerance from drug withdrawal to 12 months.
Secondary	Cumulative incidence of clinical infections resulting in hospitalization within 12 months.