Chronic allograft nephropathy in kidney transplants, defined as tubular atrophy and interstitial fibrosis in graft biopsy (Banff criteria) MedDRA version: 14.1 Level: PT Classification code 10063209 Term: Chronic allograft nephropathy System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: inspra
Pharmaceutical Form: Tablet
INN or Proposed INN: EPLERENONE
CAS Number: 107724-20-9
Other descriptive name: EPLERENONE
Concentration unit: mg milligram(s)
Concentration type: up to
Sponsors
Karl Emil Kristensen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the criteria must be fulfilled for inclusion •Men and women of 18 years or more, transplanted with a kidney from diseased or living donor, for between 1 and 3 years ago. Kidney function must be stable with a creatinine clearance at 30 ml/min or more. • Patients who have read and understood the conditions of participation of the study, as described in the patient information. • Patients, who can give an informed consent in regard to the patient information. •Patients, who are not expelled by the exclusion criteria. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients, who are pregnant and/or breastfeeding or fertile women, who are not prepared to use safe contraceptives (P-pills, hormone spiral or depot gestagene) during the time of the investigation. Pregnancy should be ruled out in fertile women by a negative pregnancy tests or the use of safe contraceptive for at least 3 months before study entry. • Patients, who are HIV, HBV, HCV positive or suffer of other serious diseases. •Patients with diarrhea or gastrointestinal illness, which can prevent adequate absorption of the study drugs. •Patients with malignant diseases, except local dermal carcinoma, treated with success. •Patients with active systemic infections. •Patients with other chronic or acute, systemic or organ specific diseases, which are debilitating the patient, in such a way, that study entry cannot be defended by the investigating doctors. •Patients with plasma potassium > 6,5 mmol/l •Patients, with any form of abuse of medical products, psychiatric disorders or other diseases, which may hamper the contacts between patient and the doctors. •Patients, enrolled in other projects involving administration of project medication or other treatment, which may affect the outcome. •Patients with allergic sensitization against the investigated drugs. •Patients treated with m-TOR blockade (sirolimus, everolimus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the possible renal graft protective effects of treatment with eplerenone in kidney transplanted patients in addition to a standard regimen, including studies in the progression of proteinuria and glomerular filtration. ;Secondary Objective: to reduce the velocety at witch the graft function is declining ;Primary end point(s): Primary endoints. 24 hour urine albumine excretion ;Timepoint(s) of evaluation of this end point: The primery endpoint will be evaluated at 3 months and one year after initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ethiological studies in CAN: • The ekspression of CYP11B2 • The ekspressionen PAI-1, TGF-ß, surrogat messures of CAN • Chrome EDTA clearance/Technetium DTPA renography • Blood pressure • weight ;Timepoint(s) of evaluation of this end point: Secondary endpoints regarding ethiological reseach will be evaluated one at initiation. Secondary endpoints regarding surrogate endpoint will be evaluated at week 0, 12, 26, 48. | — |
Countries
Denmark
Contacts
Public ContactClinical Trials Information
Rigshospitalet, Dept. of Nephrology
Outcome results
None listed