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Completed

NCT Number: NCT00514514

Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females, aged 18 - 70 years
  • Recipients of de novo cadaveric, living unrelated or living related kidney transplants
  • Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
  • Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

  • More than one previous renal transplantation
  • Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
  • Patients receiving a kidney from a non-heart beating donor
  • Donor age: < 5 years or > 70 years
  • Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Everolimus

Drug

Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen

Other names: Certican

Myfortic

Drug

1 tablet containing 180 mg or 360 mg

Dosing schedule:

Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day)

Other names: Enteric Coated Mycophenolate Sodium

Sandimmun Optoral

Drug

1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level

Other names: Cyclosporine A

Simulect®

Drug

Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4

Other names: Basiliximab

Primary outcomes

  1. GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen

    Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant

    Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted

Secondary outcomes

  1. GFR Via Nankivell Formula at Month 12 - All Regimens

    Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant

    Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

  2. GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method

    Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant

    Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:

    For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

  3. GFR at Month 12 Utilizing Cockcroft-Gault Formula

    Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant

    Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

  4. Mean Change in Serum Creatinine From Month 3 to Month 12

    Time frame: From randomization at BL2 (Month 3) to Month 12 post-transplant

    Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

  5. Efficacy Event Data From Baseline 2 (Month 3) to Month 6

    Time frame: From Baseline 2 (Month 3) to Month 6

    Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).

  6. Efficacy Event Data Baseline 2 (Month 3) to Month 12

    Time frame: From Baseline 2 (Month 3) to Month 12

    Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).

  7. Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)

    Time frame: From Baseline 2 (Month 3) to Month 12

    The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.

  8. GFR Calculated Via Nankivell Formula at Month 60

    Time frame: From randomization at BL2 (Month 3) to Month 60

    Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

  9. GFR at Month 60 Utilizing Cockcroft-Gault Formula

    Time frame: From randomization at BL2 (Month 3) to Month 60 post-transplant

    Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

  10. GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method

    Time frame: From randomization at BL2 (Month 3) to Month 60 post-transplant

    Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:

    For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

  11. Mean Change in Serum Creatinine From Month 3 to Month 60

    Time frame: From randomization at BL2 (Month 3) to Month 60 post-transplant

    Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

  12. Efficacy Event Data After Month 12 to Month 60

    Time frame: Events starting after Month 12

    Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2007
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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