The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantatio

• Conditions: Chronic allograft nephropathy in kidney transplants, defined as tubular atrophy and interstitial fibrosis in graft biopsy (Banff criteria); MedDRA version: 14.1Level: PTClassification code 10063209Term: Chronic allograft nephropathySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-002518-35-DK
• Lead Sponsor: Karl Emil Kristensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified