NEW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSION

NEW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. A MULTICENTRE, PROSPECTIVE, RANDOMIZED, OPEN STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006162-40-ES

Enrollment

Registered

2013-03-06

Start date

2013-05-28

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult kidney transplant recipients older than 45 years old with risk of developing prediabetes states after renal transplantation (PREDAT) and diabetes mellitus after renal transplantation (NODAT) MedDRA version: 15.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 15.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865

Interventions

Trade Name: NULOJIX Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Belatacept CAS Number: 706808-37-9 Other descriptive name: BELATACEPT Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age ? 45 years of age. Patients with high-risk of GMA after renal transplantation defined as: a) Patients aged ? 60 years. b) Patients aged ? 45 accomplishing one of the following combinations: b.1) Serum triglycerides > 200 mg/ml. b.2) The combination of body mass index (BMI) > 27 kg/m2 and serum triclycerides > 150 mg/ml. b.3) The combination of serum triglycerides > 150 mg/ml and serum HDL-cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Seronegative or unknown EBV serostatus Patients with tuberculosis who have not been treated for latent infection. Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection. Receiving or having previously received an organ transplant other than a kidney. Recipient of dual kidney transplantation. Recipient of a graft from a non-heart-beating donor. Cold ischemia time of the donor kidney > 30 hours. PRA >30%. Significant liver disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to compare the incidence of glucose metabolism alterations defined as per the American Diabetic Association at any time point up to 6 months after kidney transplantation;Secondary Objective: Acute rejections by signs and symptoms Biopsy confirmed acute rejections Patient survival at 6 months. Graft survival at 6 months. Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula. Reported quality of life;Primary end point(s): Incidence of GMA, either PREDAT or NODAT, defined as per ADA criteria;Timepoint(s) of evaluation of this end point: the first 6 months after transplantation	—

Measure

Time frame

Main Objective: The primary objective is to compare the incidence of glucose metabolism alterations defined as per the American Diabetic Association at any time point up to 6 months after kidney transplantation;Secondary Objective: Acute rejections by signs and symptoms Biopsy confirmed acute rejections Patient survival at 6 months. Graft survival at 6 months. Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula. Reported quality of life;Primary end point(s): Incidence of GMA, either PREDAT or NODAT, defined as per ADA criteria;Timepoint(s) of evaluation of this end point: the first 6 months after transplantation

—

Secondary

Measure	Time frame
Secondary end point(s): Acute rejections by signs and symptoms Biopsy confirmed acute rejections Patient survival at 6 months. Graft survival at 6 months. Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula. Reported quality of life;Timepoint(s) of evaluation of this end point: the first 6 months after transplantation	—

Countries

Spain

Contacts

Public ContactStudy coordinator

Dr Francesc Moreso Mateos. Hospital Vall d?Hebron/Department of Nephrology

fjmoreso@vhebron.net+34932746079

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026