Kidney Transplant Failure and RejectionPhase 4NCT04936282
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)
A Phase 4 study testing Grafalon and Normal Treatment in people with Kidney Transplant Failure and Rejection, run by Fundación Canaria Instituto de Investigación Sanitaria de Canarias at 4 sites in Spain.
Trial summary
Background: Subclinical inflammation, including borderline lesions (BL), is very common (30-40%) 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- Grafalon and Normal Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSpain
- Study dates
- 5 Jul 2022to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Presence of BL, excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0, i0).
- Patients receiving tacrolimus in combination with mycophenolic acid (MPA) and steroids.
- Absence of clinical or subclinical and histological immunological dysfunction before randomization.
- Absence of de novo DSA anti-HLA antibodies at the time of randomization.
- Provision of written informed consent.
- Acceptance of efficient contraception in women.
Who cannot join
- Recipients of a multi-organ transplant.
- Re-transplants.
- Patients without inflammation in the third month protocol biopsy (i0,t0), or with isolated inflammation without tubulitis (t0,i>0) or isolated tubulitis without inflammation (t>0,i0).
- Presence of DSA antibodies before transplantation or at randomization.
- Cold ischemia time >30 hours.
- Serum creatinine >2.5 mg/dl or proteinuria >1 g/day at randomization.
Show all 14Show fewer
- Presence of significant thrombopenia (<100,000/mm3) or leukopenia (<3000 mm/3) at randomization.
- Previous episode of clinical or subclinical rejection (≥IA) before randomization.
- CMV disease in the first three months after transplantation.
- BK-polyomavirus nephropathy at randomization.
- Recurrent or de novo glomerulonephritis.
- Treatment with immunosuppressive drugs other than those in this clinical trial.
- 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.
- Previous (within the last 5 years) or present malignancy, except excised basal or squamous cell carcinoma.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Fundación Puigvert
Barcelona, Barcelona, 08025
Hospital Universitari Valld´Hebron
Barcelona, Barcelona, 08035
Veronica Lopez Jimenez
Málaga, MALAGA, 29010
Hospital Universitario de Canarias
Santa Cruz de Tenerife, None Selected, 38320
About this study
Official title: Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study
Background: Subclinical inflammation, including borderline lesions (BL), is very common (30-40%) 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. Few controlled studies have analyzed the therapeutic benefit of these BL on renal function and graft histology. Furthermore, these studies have only used bolus steroids, which may be insufficient to slow the progression of these lesions. Klotho, a transmembrane protein produced mainly in the kidney with antifibrotic properties, plays a crucial role in the senescence-inflammation binomial of kidney tissue. Systemic and local inflammation decrease renal tissue expression and soluble levels of α-klotho. It is therefore important to determine whether treatment of BL prevents a decrease in α klotho levels, progression of IFTA, and loss of kidney function.
Methods: The TRAINING study will randomize 80 patients with low immunological risk who will receive their first KT. The aim of the study is to determine whether the treatment of early BL (3rd month post-KT) with polyclonal rabbit antithymocyte globulin (Grafalon®) (6 mg/kg/day) prevents or decreases the progression of IFTA and the worsening of graft function compared to conventional therapy after two years post-TX, as well as to analyze whether treatment of BL with Grafalon® can modify the expression and levels of klotho, as well as the pro-inflammatory cytokines that regulate its expression.
- Conditions
- Kidney Transplant Failure and Rejection
- Being tested
- Grafalon, Normal Treatment
- Keywords
- borderline lesions, α-klotho, low immunological risk, subclinical inflammation, kidney transplant
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrafalonDrug
When Borderline lesions are present in protocol biopsy, administer Grafalon ® 6 mg/kg/day in a single day. Then continue with the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day).
Normal TreatmentDrug
When Borderline lesions are present in protocol biopsy, administer the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Normal treatment (Steroids, tacrolimus and mycophenolate) for first 90 days, then add Grafalon single-dose if borderline lesions are present in protocol biopsy (performed at third month post-transplantation). Receives: Drug: Grafalon |
| Normal treatment | Active comparator | Normal treatment (Steroids, tacrolimus and mycophenolate) arm Receives: Drug: Normal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of interstitial fibrosis/tubular atrophy (IFTA)
Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant.
Measured: 24 months
Renal function measured with CKD-EPI
Renal function after kidney transplant in both groups at 24 months measured according to glomerular filtration rate determined by CKD-EPI formula
Measured: 24 months
Secondary outcomes (8)
Graft Survival
Graft survival after kidney transplant in both groups
Measured: 24 months
Patient Survival
Patient survival after kidney transplant in both groups
Measured: 24 months
Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups
The Basle scale was used to assess adherence to immunosuppressive therapy.
Measured: 24 months
Incidence of Diabetes Mellitus
Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months
Measured: 24 months
Blood Pressure mmHg
Blood pressure after kidney transplant in both groups at 24 months
Measured: 24 months
Number of Participants With Acute Rejection Lesions
Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification
Measured: 24 months
Lipid Profile cholesterol, triglycerides
Lipid profile after kidney transplant in both groups at 24 months
Measured: 24 months
Klotho levels pg/ml
Klotho levels after kidney transplant in both groups at 1, 3, 6, 12 and 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start5 Jul 2022
- Primary completionJun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936282
- Sponsor's protocol ID
- TRAINING
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riella LV, Djamali A, Pascual J. Chronic allograft injury: Mechanisms and potential treatment targets. Transplant Rev (Orlando). 2017 Jan;31(1):1-9. doi: 10.1016/j.trre.2016.10.005. Epub 2016 Oct 11.
PubMed 27847221Kasiske BL, Gaston RS, Gourishankar S, Halloran PF, Matas AJ, Jeffery J, Rush D. Long-term deterioration of kidney allograft function. Am J Transplant. 2005 Jun;5(6):1405-14. doi: 10.1111/j.1600-6143.2005.00853.x.
PubMed 15888048Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR. The natural history of chronic allograft nephropathy. N Engl J Med. 2003 Dec 11;349(24):2326-33. doi: 10.1056/NEJMoa020009.
PubMed 14668458Garcia-Carro C, Dorje C, Asberg A, Midtvedt K, Scott H, Reinholt FP, Holdaas H, Seron D, Reisaeter AV. Inflammation in Early Kidney Allograft Surveillance Biopsies With and Without Associated Tubulointerstitial Chronic Damage as a Predictor of Fibrosis Progression and Development of De Novo Donor Specific Antibodies. Transplantation. 2017 Jun;101(6):1410-1415. doi: 10.1097/TP.0000000000001216.
PubMed 27163535Ortiz F, Gelpi R, Helantera I, Melilli E, Honkanen E, Bestard O, Grinyo JM, Cruzado JM. Decreased Kidney Graft Survival in Low Immunological Risk Patients Showing Inflammation in Normal Protocol Biopsies. PLoS One. 2016 Aug 17;11(8):e0159717. doi: 10.1371/journal.pone.0159717. eCollection 2016.
PubMed 27532630Rush DN, Gibson IW. Subclinical Inflammation in Renal Transplantation. Transplantation. 2019 Jun;103(6):e139-e145. doi: 10.1097/TP.0000000000002682.
PubMed 30801537Nankivell BJ, Agrawal N, Sharma A, Taverniti A, P'Ng CH, Shingde M, Wong G, Chapman JR. The clinical and pathological significance of borderline T cell-mediated rejection. Am J Transplant. 2019 May;19(5):1452-1463. doi: 10.1111/ajt.15197. Epub 2019 Jan 22.
PubMed 30501008Moreso F, Ibernon M, Goma M, Carrera M, Fulladosa X, Hueso M, Gil-Vernet S, Cruzado JM, Torras J, Grinyo JM, Seron D. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant. 2006 Apr;6(4):747-52. doi: 10.1111/j.1600-6143.2005.01230.x.
PubMed 16539631Mehta RB, Tandukar S, Jorgensen D, Randhawa P, Sood P, Puttarajappa C, Zeevi A, Tevar AD, Hariharan S. Early subclinical tubulitis and interstitial inflammation in kidney transplantation have adverse clinical implications. Kidney Int. 2020 Aug;98(2):436-447. doi: 10.1016/j.kint.2020.03.028. Epub 2020 Apr 25.
PubMed 32624181Mehta R, Bhusal S, Randhawa P, Sood P, Cherukuri A, Wu C, Puttarajappa C, Hoffman W, Shah N, Mangiola M, Zeevi A, Tevar AD, Hariharan S. Short-term adverse effects of early subclinical allograft inflammation in kidney transplant recipients with a rapid steroid withdrawal protocol. Am J Transplant. 2018 Jul;18(7):1710-1717. doi: 10.1111/ajt.14627. Epub 2018 Jan 17.
PubMed 29247472Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.
PubMed 32463180Beimler J, Zeier M. Borderline rejection after renal transplantation--to treat or not to treat. Clin Transplant. 2009 Dec;23 Suppl 21:19-25. doi: 10.1111/j.1399-0012.2009.01105.x.
PubMed 19930312Kee TY, Chapman JR, O'Connell PJ, Fung CL, Allen RD, Kable K, Vitalone MJ, Nankivell BJ. Treatment of subclinical rejection diagnosed by protocol biopsy of kidney transplants. Transplantation. 2006 Jul 15;82(1):36-42. doi: 10.1097/01.tp.0000225783.86950.c2.
PubMed 16861939Park SH, Friedewald JJ. Are borderline changes real rejection? Current viewpoints. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):656-662. doi: 10.1097/MNH.0000000000000648.
PubMed 32889982Opelz G, Naujokat C, Daniel V, Terness P, Dohler B. Disassociation between risk of graft loss and risk of non-Hodgkin lymphoma with induction agents in renal transplant recipients. Transplantation. 2006 May 15;81(9):1227-33. doi: 10.1097/01.tp.0000219817.18049.36.
PubMed 16699447
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study
- ClinicalTrials.gov ID
- NCT04936282
- Acronym / sponsor ID
- TRAINING
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- borderline lesions, α-klotho, low immunological risk, subclinical inflammation, kidney transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundación Canaria Instituto de Investigación Sanitaria de CanariasUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Subclinical inflammation, including borderline lesions (BL), is very common (30-40%) 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. Few controlled studies have analyzed the therapeutic benefit of these BL on renal function and graft histology. Furthermore, these studies have only used bolus steroids, which may be insufficient to slow the progression of these lesions. Klotho, a transmembrane protein produced mainly in the kidney with antifibrotic properties, plays a crucial role in the senescence-inflammation binomial of kidney tissue. Systemic and local inflammation decrease renal tissue expression and soluble levels of α-klotho. It is therefore important to determine whether treatment of BL prevents a decrease in α klotho levels, progression of IFTA, and loss of kidney function.
Methods: The TRAINING study will randomize 80 patients with low immunological risk who will receive their first KT. The aim of the study is to determine whether the treatment of early BL (3rd month post-KT) with polyclonal rabbit antithymocyte globulin (Grafalon®) (6 mg/kg/day) prevents or decreases the progression of IFTA and the worsening of graft function compared to conventional therapy after two years post-TX, as well as to analyze whether treatment of BL with Grafalon® can modify the expression and levels of klotho, as well as the pro-inflammatory cytokines that regulate its expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: GrafalonNormal treatment (Steroids, tacrolimus and mycophenolate) for first 90 days, then add Grafalon single-dose if borderline lesions are present in protocol biopsy (performed at third month post-transplantation). |
| Normal treatment | Active comparator | Drug: Normal TreatmentNormal treatment (Steroids, tacrolimus and mycophenolate) arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Presence of BL, excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0, i0).
- Patients receiving tacrolimus in combination with mycophenolic acid (MPA) and steroids.
- Absence of clinical or subclinical and histological immunological dysfunction before randomization.
- Absence of de novo DSA anti-HLA antibodies at the time of randomization.
Key exclusion criteria (14 listed)
- Recipients of a multi-organ transplant.
- Re-transplants.
- Patients without inflammation in the third month protocol biopsy (i0,t0), or with isolated inflammation without tubulitis (t0,i>0) or isolated tubulitis without inflammation (t>0,i0).
- Presence of DSA antibodies before transplantation or at randomization.
- Cold ischemia time >30 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrafalonWhen Borderline lesions are present in protocol biopsy, administer Grafalon ® 6 mg/kg/day in a single day. Then continue with the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day). | Drug | Experimental |
| Normal TreatmentWhen Borderline lesions are present in protocol biopsy, administer the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day) | Drug | Normal treatment |
Primary outcome
Presence of interstitial fibrosis/tubular atrophy (IFTA)
Time frame: 24 months
Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant.
Renal function measured with CKD-EPI
Time frame: 24 months
Renal function after kidney transplant in both groups at 24 months measured according to glomerular filtration rate determined by CKD-EPI formula
8 secondary outcomes
Graft Survival
Time frame: 24 months
Patient Survival
Time frame: 24 months
Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups
Time frame: 24 months
Incidence of Diabetes Mellitus
Time frame: 24 months
Blood Pressure mmHg
Time frame: 24 months
Number of Participants With Acute Rejection Lesions
Time frame: 24 months
Lipid Profile cholesterol, triglycerides
Time frame: 24 months
Klotho levels pg/ml
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 27847221Riella LV, Djamali A, Pascual J. Chronic allograft injury: Mechanisms and potential treatment targets. Transplant Rev (Orlando). 2017 Jan;31(1):1-9. doi: 10.1016/j.trre.2016.10.005. Epub 2016 Oct 11.
- Background: PubMed 15888048Kasiske BL, Gaston RS, Gourishankar S, Halloran PF, Matas AJ, Jeffery J, Rush D. Long-term deterioration of kidney allograft function. Am J Transplant. 2005 Jun;5(6):1405-14. doi: 10.1111/j.1600-6143.2005.00853.x.
- Background: PubMed 14668458Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR. The natural history of chronic allograft nephropathy. N Engl J Med. 2003 Dec 11;349(24):2326-33. doi: 10.1056/NEJMoa020009.
- Background: PubMed 27163535Garcia-Carro C, Dorje C, Asberg A, Midtvedt K, Scott H, Reinholt FP, Holdaas H, Seron D, Reisaeter AV. Inflammation in Early Kidney Allograft Surveillance Biopsies With and Without Associated Tubulointerstitial Chronic Damage as a Predictor of Fibrosis Progression and Development of De Novo Donor Specific Antibodies. Transplantation. 2017 Jun;101(6):1410-1415. doi: 10.1097/TP.0000000000001216.
- Background: PubMed 27532630Ortiz F, Gelpi R, Helantera I, Melilli E, Honkanen E, Bestard O, Grinyo JM, Cruzado JM. Decreased Kidney Graft Survival in Low Immunological Risk Patients Showing Inflammation in Normal Protocol Biopsies. PLoS One. 2016 Aug 17;11(8):e0159717. doi: 10.1371/journal.pone.0159717. eCollection 2016.
- Background: PubMed 30801537Rush DN, Gibson IW. Subclinical Inflammation in Renal Transplantation. Transplantation. 2019 Jun;103(6):e139-e145. doi: 10.1097/TP.0000000000002682.
- Background: PubMed 30501008Nankivell BJ, Agrawal N, Sharma A, Taverniti A, P'Ng CH, Shingde M, Wong G, Chapman JR. The clinical and pathological significance of borderline T cell-mediated rejection. Am J Transplant. 2019 May;19(5):1452-1463. doi: 10.1111/ajt.15197. Epub 2019 Jan 22.
- Background: PubMed 16539631Moreso F, Ibernon M, Goma M, Carrera M, Fulladosa X, Hueso M, Gil-Vernet S, Cruzado JM, Torras J, Grinyo JM, Seron D. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant. 2006 Apr;6(4):747-52. doi: 10.1111/j.1600-6143.2005.01230.x.
- Background: PubMed 32624181Mehta RB, Tandukar S, Jorgensen D, Randhawa P, Sood P, Puttarajappa C, Zeevi A, Tevar AD, Hariharan S. Early subclinical tubulitis and interstitial inflammation in kidney transplantation have adverse clinical implications. Kidney Int. 2020 Aug;98(2):436-447. doi: 10.1016/j.kint.2020.03.028. Epub 2020 Apr 25.
- Background: PubMed 29247472Mehta R, Bhusal S, Randhawa P, Sood P, Cherukuri A, Wu C, Puttarajappa C, Hoffman W, Shah N, Mangiola M, Zeevi A, Tevar AD, Hariharan S. Short-term adverse effects of early subclinical allograft inflammation in kidney transplant recipients with a rapid steroid withdrawal protocol. Am J Transplant. 2018 Jul;18(7):1710-1717. doi: 10.1111/ajt.14627. Epub 2018 Jan 17.
- Background: PubMed 32463180Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.
- Background: PubMed 19930312Beimler J, Zeier M. Borderline rejection after renal transplantation--to treat or not to treat. Clin Transplant. 2009 Dec;23 Suppl 21:19-25. doi: 10.1111/j.1399-0012.2009.01105.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grafalon and Normal Treatment in people with Kidney Transplant Failure and Rejection, run by Fundación Canaria Instituto de Investigación Sanitaria de Canarias at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of interstitial fibrosis/tubular atrophy (IFTA) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936282, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.