Single-center, single-armed, open-label, prospective study assessing efficacy and safety of a conversion of kidney allograft recipients suffering from Chronic Allograft Nephropathy (CAN) assessed by GFR-slope analysis to an Everolimus-based regimen to improve renal function - ProCA

• Conditions: This study is designed to assess whether a conversion from a CNI-based therapy to a CNI-free therapy with Certican® and Myfortic® in renal transplant patients with Chronic Allograft Nephropathy (CAN) is able to improve renal function. The study is investigating the efficacy of a conversion from a CNI-based to a CNI-free therapy and should show that this switch is safe and well tolerated.; MedDRA version: 12.1Level: LLTClassification code 10023438Term: Kidney transplant

• Registration Number: EUCTR2010-018792-17-DE
• Lead Sponsor: Kliniken der Stadt Koeln gGmbH, Klinikum Merheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males or females, aged >18 years
2. Renal transplant recipients suffering from Chronic Allograft Nephropathy (CAN) defined as having a statistically evident decrease in the GFR-slope at least 6 months prior to baseline. GFR-slope is calculated for the period from the day of TX until baseline (at least 6 months post transplantation) or at least 6 months before baseline and must have a significant negative slope as calculated by described statistic method (chapter 10.4.2). At least 5 GFR-values have to be present for slope-calculation. A renal biopsy at Baseline Visit will be performed to confirm the presence of CAN. This renal bisopsy may be taken within three months before Baseline visit
3. Allowed time interval between renal transplantation and Baseline Visit is = 6 months
4. Patients receiving Myfortic® / MMF and a CNI (Sandimmun® Optoral or Prograf®) with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline
5. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, 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 (see also chapter 8.2)
6. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than one previous renal transplantation
2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
3. Patient with proteinuria > 1g/day total Protein in Urine or > 500mg/day Albumin in Urine at baseline
4. Patients with hypersensitivity to Certican®, mycophenolic acid, or other components of the formulation (e.g. lactose; see also SPCs)
5. Patients who have received an investigational drug within four weeks prior to baseline
6. Patients who suffered from severe rejection (more than or equal to BANFF II acute rejection), recurrent acute rejection, or steroid resistant rejection within 6 months of enrollment in this trial (baseline). A renal biopsy at Baseline Visit will be performed to exclude any signs of rejection. This renal biopsy may taken within 3 month before Baseline visit
7. Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 4,000/mm³), or hemoglobin < 8 g/dL
8. Abnormal physical or laboratory findings of clinical significance within 2 weeks of study inclusion (baseline) which at investigator discretion would interfere with the objectives of the study
9. Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
10. Patients with a history of malignancy during the last five years, except squamos or basal cell carcinoma of the skin
11. Patients who are HIV positive, or Hepatitis C-, or Hepatitis B surface antigen positive
12. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
13. Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contraception
14. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
15. Evidence of drug or alcohol abuse

Study & Design

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