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

NCT00148252 | Terminated Phase 4

• 1 other identifier: NILS 02-08144
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

Renal Transplantation

Keywords

Calcineurin; reduction; immunosuppression; cyclosporine A; mycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Graft and patient survival at 12 months and 5 years posttransplant.

• Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episodes within 12 months.

• Incidence of HB, WBC, platelet abnormal values requiring clinical intervention within 12 months.

• Incidence of need for additional immunosuppressive therapy at 12 months.

• Absolute difference in renal function between treatment groups at 12 months, evaluated by Nankivell's formula (B).

Interventions

Mycophenolate mofetil withdrawal DRUG

Cyclosporione A withdrawal DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo School of Pharmacy: lead

Study Sites (9)

Rikshospitalet, Section of Nephrology

Oslo, Oslo County, 0027, Norway

Location

Haukeland sykehus

Bergen, 5021, Norway

Location

Lillehammer hospital

Lillehammer, 2609, Norway

Location

Akershus Hospital

Nordbyhagen, 1474, Norway

Location

Ullevål hospital

Oslo, 0450, Norway

Location

Hospital Telemark

Skien, 3710, Norway

Location

Sentralsykehuset i Rogaland

Stavanger, 4068, Norway

Location

Tromsø hospital

Tromsø, 9038, Norway

Location

St. Olavs hospital

Trondheim, 7030, Norway

Location

Related Publications (1)

• Asberg A, Apeland T, Reisaeter AV, Foss A, Leivestad T, Heldal K, Thorud LO, Eriksen BO, Hartmann A; NILS Study Group. Long-term outcomes after cyclosporine or mycophenolate withdrawal in kidney transplantation - results from an aborted trial. Clin Transplant. 2013 Mar-Apr;27(2):E151-6. doi: 10.1111/ctr.12076. Epub 2013 Jan 27.

  PMID: 23351013 DERIVED

Study Officials

• Anders Åsberg, MSc

  University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: February 1, 2003
• Primary Completion: November 1, 2005
• Study Completion: February 1, 2007
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

NO (9)