Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10049581Term: Graft rejection episodeSystem Organ Class: 100000004870; Subclinical inflammation, including borderline lesions (BL), is very common after kidney transplantation (KT), even in low immunological risk patients, and can lead to interstitial fibrosis/tubular atrophy (IFTA) and worsening of renal function with graft loss. The aim of the study is to determine whether the treatment of early BL (3rd month post-KT) with Grafalon decreases the progression of IFTA and the worsening of graft function compared to conventional therapy after two years post-KT.; MedDRA version: 21.1Level: LLTClassification code 10018650Term: Graft rejectionSystem Organ Class: 100000004870; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2021-003089-11-ES
• Lead Sponsor: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Patients of either sex, older than 18 years, with no immunological risk (PRA<20% and absence of DSA), who receive their first deceased donor or living donor KT.

2) Presence of BL, excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0, i0).

3) Patients receiving tacrolimus in combination with mycophenolic acid (MPA) and steroids.

4) Absence of clinical or subclinical and histological immunological dysfunction before randomization.

5) Absence of de novo DSA anti-HLA antibodies at the time of randomization.

6) Provision of written informed consent.

7) Acceptance of efficient contraception in women.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1) Recipients of a multi-organ transplant.

2) Re-transplants.

3) Cold ischemia time >30 hours.

4) Serum creatinine >2 mg/dl or proteinuria >1 g/day at randomization.

5) Presence of significant thrombopenia (<100,000/mm3) or leukopenia (<3000 mm/3) at randomization.

6) Previous episode of clinical or subclinical rejection (=IA) before randomization.

7) Presence of BL before randomization.

8) CMV infection or disease in the first three months after transplantation.

9) BK-polyomavirus nephropathy at randomization.

10) Recurrent or de novo glomerulonephritis.

11) Treatment with immunosuppressive drugs other than those in this clinical trial.

12) Patients who are positive for the human immunodeficiency virus (HIV) or with severe systemic infection, who, in the opinion of the investigator, require continued therapy.

13) Previous (within the last 5 years) or present malignancy, except excised basal or squamous cell carcinoma.

Study & Design

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