EUCTR2011-002518-35-DK
Active, not recruiting
Not Applicable
The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantation - CODE-CA
Karl Emil Kristensen0 sites60 target enrollmentFebruary 1, 2012
ConditionsTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Sponsor
- Karl Emil Kristensen
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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