A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
ADHERE
A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients
2 other identifiers
interventional
853
15 countries
54
Brief Summary
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2011
Typical duration for phase_4
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2011
CompletedFirst Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2013
CompletedOctober 31, 2024
October 1, 2024
2.5 years
May 31, 2011
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantation
up to 1 year
Secondary Outcomes (11)
Efficacy failure
up to 1 year
GFR at Week 52 post kidney transplantation by Modification Diet in Renal Disease (MDRD) formula
up to 1 year
GFR at Week 52 post kidney transplantation by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
up to 1 year
Calculated creatinine clearance at Week 52 post kidney transplantation by Cockcroft and Gault formula
up to 1 year
Incidence of clinical acute rejection
up to 1 year
- +6 more secondary outcomes
Study Arms (2)
Advagraf + MMF + Steroids
ACTIVE COMPARATORWithout sirolimus
Advagraf + MMF + Steroids + Sirolimus
EXPERIMENTALWith sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28
Interventions
oral
oral
Eligibility Criteria
You may qualify if:
- End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
- Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen \[HLA\] identical) donor with compatible ABO blood type
- Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
- Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
You may not qualify if:
- Receiving or having previously received an organ transplant other than a kidney
- Cold ischemia time of the donor kidney \> 30 hours
- Panel Reactive Antibody (PRA) \>20%
- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
- Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
- Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
- Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- Pregnant woman or breast-feeding mother
- Subject or donor known to be HIV positive
- Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
- Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
- Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
- Unlikely to comply with the visits scheduled in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
5042
New Lambton, NSW 2305, Australia
5043
Perth, WA 6009, Australia
1141
Innsbruck, 6020, Austria
1142
Linz, 4020, Austria
1140
Vienna, 1090, Austria
3240
Minsk, 220116, Belarus
1241
Leuven, 3000, Belgium
1240
Liège, 4000, Belgium
Site 1441
Brno, 656 91, Czechia
1440
Ostrava - Poruba, 78 52, Czechia
1752
Amiens, 80054, France
1740
Brest, 29609, France
1742
Clermont-Ferrand, 63003, France
1746
Créteil, 94010, France
1750
Dijon, 21000, France
1741
Le Kremilin Bicetre Cedex, 94275, France
1749
Paris, 75743, France
1751
Toulouse, 31059, France
1748
Tours, 37044, France
1745
Vandœuvre-lès-Nancy, 54511, France
1541
Bochum, 44892, Germany
1542
Erlangen, 91054, Germany
1543
Essen, 45147, Germany
1544
Frankfurt, 60596, Germany
1545
Hannoversch Münden, 34346, Germany
1540
Hanover, 30625, Germany
1546
Heidelberg, 69120, Germany
1547
Kiel, 24105, Germany
1548
Leipzig, 04103, Germany
1549
München, 81377, Germany
1550
Münster, 48149, Germany
5441
Hong Kong, Hong Kong
1940
Budapest, 1082, Hungary
2144
Palermo, 90124, Italy
2143
Roma, 00168, Italy
2140
Siena, 53100, Italy
2440
Maastricht, 6229 HX, Netherlands
2643
Katowice, 40-027, Poland
2640
Lodz, 91-153, Poland
2641
Poznan, 60-479, Poland
2841
Kemerovo, 650066, Russia
2843
Moscow, 115446, Russia
2842
Omsk, 644112, Russia
2840
Vol'ginskiy, 404120, Russia
5245
Busan, 614-735, South Korea
5243
Daegu, 700-721, South Korea
5242
Seoul, 110-744, South Korea
5241
Seoul, 120-752, South Korea
5244
Seoul, 138-736, South Korea
1640
Alicante, 03010, Spain
1641
Barcelona, 08907, Spain
1643
Santander, 39008, Spain
1642
Vizcaya, 48903, Spain
5343
Tainan, 70403, Taiwan
5342
Taoyuan District, 33305, Taiwan
3042
Istanbul, 07058, Turkey (Türkiye)
3043
Istanbul, 34245, Turkey (Türkiye)
3044
Istanbul, 34732, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 2, 2011
Study Start
March 8, 2011
Primary Completion
September 18, 2013
Study Completion
September 18, 2013
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.