Evaluation of Immunobiogram® as a Tool in Adjustment of Immunosuppressant Therapy for Renal Transplant

NCT03562845 | Completed

• 1 other identifier: BHP-IBG-2017-01
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant can help predict how well the immune system is working and responding to a new kidney. These blood tests could, in the future, potentially guide how doctors manage patient's anti-rejection medication.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Evaluate the robustness of Immunobiogram® (IMBG) as an in vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation

  Robustness of Immunobiogram® (IMBG) as an In Vitro Diagnostic Bioassay to study the sensitivity/resistance patterns of Immunosuppressant drugs in Renal Transplantation, evaluated as follows: * Immunobiogram® offers personal sensitivity/resistance patterns of Immunosuppressive Medications (IM), with a range of responses for each IM drug considering all patients included * Immunobiogram® shows intrasubject consistency in terms of similarity with a maximum +/- 20% of variation in the inhibitory dose/distance 50 (ID50), in the three IMBG performed on inclusion; and additionally, similar consistency must be observed in the last three IMBG performed one month after inclusion

  Baseline and 30 days

Secondary Outcomes (2)

• Evaluate intrasubject and inter-time consistency of Immunobiogram®

  Baseline and 30 days

• Evaluate the correlation of Immunobiogram® sensitivity/resistance patterns with clinical evolution

  Baseline

Study Arms (2)

ARM 1-Bad vs Good Clinical Evolution

This arm is intended to evaluate the correlation of Immunobiogram® sensitivity/resistance patterns with clinical prognosis as it may be judged at this moment considering clinical outcomes and immune-biomarker evolution in the past 12 to 18 months. Thus, it may confirm the BH-Pilot study findings. Renal transplant patients of two types will be included: * Patients who, over previous months, have had a bad clinical evolution, in which rejection mechanisms were involved * Patients with a good and stable clinical evolution IMBG sensitivity/resistance profiles will be compared amongst the two groups to evaluate the differences.

Other: NA-Observational only

ARM 2-Stable Renal Transplant Patients

This arm is intended to evaluate robustness of Immunobiogram® as an IVD test. Thus, it will be performed intrasubject comparisons and inter-time evaluation of two sets of Immunobiogram® separated by 30+/- 10 days, each including three IMBG determinations (IMBGx3 - IMBGx3, the two sets separated by 30+/- 10 days). The intended evaluation will be to analyse the similarities between all IMBG tests performed, both between the same set and also between the two sets planned.

Other: NA-Observational only

Interventions

NA-Observational only OTHER

NA-Observational only

ARM 1-Bad vs Good Clinical Evolution; ARM 2-Stable Renal Transplant Patients

Eligibility Criteria

• Age: 25 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects \<25 to \< 70 years in age who have had a renal transplant performed at least one year before inclusion in the study

You may qualify if:

• Age \> 25 years and \< 70 years.
• Male and Female.
• ARM 1:
• Bad clinical evolution: patients with renal dysfunction and positive biopsy to rejection OR significant increase in strength of DSA expressed as Luminex MFI. Specifically, the following two criteria must comply:
• Renal function progressive deterioration, with significant creatinine increase of at least 15% for 18 months and/or proteinuria over \> 500 mg/day or ratio protein/creatinine\> 500 mg/g DE NOVO or increase in 50%.
• Biopsy in the last 12 months that shows positive signs attributable to any kind of immunological response compatible with any type of rejection AND/OR at least 50% increase in strength of DSA expressed as Luminex MFI in comparison with previous determination and always at titers more than 3000UI.
• Good clinical evolution: patients without rejection episodes, negative DSA, stable renal function and no changes in treatment in the past 12 months. ALL the following criteria must apply
• Stable renal function in the past 12 months
• NO DSA titers
• No history of previous rejection episodes
• Stable immunosuppressive medication (No change in prednisone or MPA dose and tacrolimus dose with changes \<20% of the dose) in the past 12 months
• ARM 2:
• Stable renal function
• No DSA titers
• No history of previous rejection episodes

You may not qualify if:

• Rejection of informed consent
• Active systemic infections that needed antimicrobial treatment in the past two months
• Active immune-based diseases with acute outbreaks in the past 12 months, despite immunosuppressive treatment
• Severe ischemia-reperfusion injury of current renal transplant with delayed graft function objectively evident at more than 20 days after transplant AND/OR kidney transplanted from a deceased, very elderly donor (\>80 years)
• Double transplant (renal + another organ)
• HIV, HBV, HCV infection or other severe infectious diseases that prevent blood samples from being processed in a conventional laboratory
• Chronic Allograft Injury (CAI) unlikely related to immune processes, by the Investigator´s judgement
• Recurrent primary kidney disease

Sponsors & Collaborators

• Biohope Scientific Solutions for Human Health, S.L.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Julio Pascual, MD, PhD

  Parc du Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 20, 2018
• Study Start: June 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)