Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation

Optimum Immunosuppression in Renal Transplant Recipients at High Risk of Developing New Onset Diabetes After Transplantation: A Multicenter, Prospective, Controlled and Randomized Trial.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002339

Acronym

01-DMPT

Enrollment

134

Registered

2009-10-27

Start date

2010-02-28

Completion date

2015-06-30

Last updated

2024-10-22

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

Conditions

Diabetes Mellitus, Adult-Onset

Brief summary

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.

Detailed description

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, increases 2 times the risk of NODAT as compared to CsA. Objectives: a) To compare the incidence of NODAT and glucose intolerance with 3 different regimes: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; and CsA with steroid minimization; b) To compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. A total of 210 patients will be randomized. The primary efficacy variable will be NODAT or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.

Interventions

DRUGTacrolimus with rapid steroid withdrawal

* Basiliximab induction (4 mg i.v., days 0 and 4). * Corticosteroids: 0.5 gr of i.v. Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. * Tacrolimus: 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml. * Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.

DRUGTacrolimus with steroids minimization

* Basiliximab induction (4 mg i.v., days 0 an 4) * Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months. * Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml. * Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.

DRUGCsA with steroid minimization

* Basiliximab induction (4 mg i.v., days 0 an 4) * Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months. * CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month and then 100-150 ng/ml. * Mycophenolate mofetil 1 gr b.i.d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary renal transplant recipients with end stage renal disease * No prior history of diabetes mellitus before transplant * Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) \< 50% * Absence of severe infection and hepatitis C or B infection * Efficient contraception in women during the study Additionally must meet one of these Metabolic Criteria * Recipient age \>or =60 or * Recipient age between 45 and 59 years and at least one of the following metabolic criteria: Prior to transplantation Triglycerides (TGS) \>200mg/dl or the combination of a body mass index (BMI)\> 27 and Triglycerides\>150 mg/dl or the combination of HDL-cholesterol\<40 mg/dl for men or \<50 mg/dl for women and Triglycerides \>150 mg/dl.

Exclusion criteria

* Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria * Recipient age under 45 * Patients receiving a second renal transplant * Patients with high immunological risk or PRA (panel reactive antibody level) \>or =50% * Severe infection or hepatitis C or B infection. * Dual renal transplant or double transplant with any other organ.

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	1 year	American Diabetes Association criteria (ADA) including an oral glucose tolerance test.
Patients Treated With Insulin or Oral Antidiabetic Drugs	1 year	—
Primary Outcome Measure (Glucose Intolerance)	1 year	Glycemia \>=140 and \<200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.

Secondary

Measure	Time frame	Description
Blood Pressure	1 year	Systolic pressure (mmHg)
Number of Antihypertensive Drugs Patients Reported Taking.	1 year	—
Lipidic Profile (Triglycerides)	1 year	—
Lipidic Profile (Cholesterol)	1 year	Lipidic Profile (total cholesterol)
Rejection	1 year	Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.
Lipidic Profile (LDL-c)	1 year	—
Percentage of Patients Using Statins	1 year	—
Changes of Carotid Intima-media Thickness Over Time	1 year	absolute difference between carotid intima-media thickness at study end versus baseline.
Percentage of Patients Using Acetylsalicylic Acid (ASA)	1 year	—
Lipidic Profile (HDL-c)	1 year	—
Renal Function	1 year	Estimated Glomerular Filtration Rate (ml/min/1.73 m\^2)
Proteinuria	1 year	—

Countries

Spain

Participant flow

Recruitment details

February 2010

Participants by arm

Arm	Count
Tacrolimus With Rapid Steroid Withdrawal Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week. Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).	44
Tacrolimus With Steroids Minimization Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).	42
CsA With Steroid Minimization CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).	42
Total	128

Withdrawals & dropouts

Period	Reason	FG001	FG002
Overall Study	Incorrect treatment assignment	0	1
Overall Study	Lung cancer detected before transplant	0	1
Overall Study	Protocol Violation	0	2
Overall Study	Randomized. Not transplanted	0	1
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Tacrolimus With Rapid Steroid Withdrawal	Total	CsA With Steroid Minimization	Tacrolimus With Steroids Minimization
Age, Continuous	61.2 years STANDARD_DEVIATION 7.6	61.0 years STANDARD_DEVIATION 7.7	60.2 years STANDARD_DEVIATION 8.3	61.6 years STANDARD_DEVIATION 7.3
Age of the donor	62.11 years STANDARD_DEVIATION 10.43	62.20 years STANDARD_DEVIATION 9.75	61.62 years STANDARD_DEVIATION 10.02	62.88 years STANDARD_DEVIATION 8.92
Anti-HLA lymphocytotoxic antibodies against <25% a reference panel No Antibodies	41 participants	121 participants	40 participants	40 participants
Anti-HLA lymphocytotoxic antibodies against <25% a reference panel Not available	0 participants	3 participants	1 participants	2 participants
Anti-HLA lymphocytotoxic antibodies against <25% a reference panel Yes	3 participants	4 participants	1 participants	0 participants
Body Mass Index (BMI)	26.95 kg/m^2 STANDARD_DEVIATION 3.71	27.57 kg/m^2 STANDARD_DEVIATION 3.84	27.94 kg/m^2 STANDARD_DEVIATION 4.08	27.87 kg/m^2 STANDARD_DEVIATION 3.72
Cold ischemia time	16.83 hours STANDARD_DEVIATION 5.52	17.41 hours STANDARD_DEVIATION 5.75	17.26 hours STANDARD_DEVIATION 6.36	18.15 hours STANDARD_DEVIATION 5.4
Donor creatinine levels	0.80 mg/dl STANDARD_DEVIATION 0.28	0.83 mg/dl STANDARD_DEVIATION 0.32	0.87 mg/dl STANDARD_DEVIATION 0.29	0.83 mg/dl STANDARD_DEVIATION 0.4
Familiar history of diabetes (N) No	35 participants	94 participants	30 participants	29 participants
Familiar history of diabetes (N) Not available	6 participants	18 participants	3 participants	9 participants
Familiar history of diabetes (N) Yes	3 participants	16 participants	9 participants	4 participants
Fasting blood glucose level	91.91 mg/dl STANDARD_DEVIATION 13.16	93.85 mg/dl STANDARD_DEVIATION 13.96	91.90 mg/dl STANDARD_DEVIATION 13.93	97.74 mg/dl STANDARD_DEVIATION 14.29
Glycated hemoglobin	5.27 percentage STANDARD_DEVIATION 0.51	5.31 percentage STANDARD_DEVIATION 0.43	5.31 percentage STANDARD_DEVIATION 0.43	5.37 percentage STANDARD_DEVIATION 0.32
HDL-c	40.95 mg/dl STANDARD_DEVIATION 14.37	41.85 mg/dl STANDARD_DEVIATION 13.92	42.21 mg/dl STANDARD_DEVIATION 15.27	42.50 mg/dl STANDARD_DEVIATION 12.07
Human leucocyte antigens (HLA) class I (A, B) and class II (DR) incompatibilities	3.55 number of incompatibilities STANDARD_DEVIATION 1.17	3.93 number of incompatibilities STANDARD_DEVIATION 1.1	4.24 number of incompatibilities STANDARD_DEVIATION 1.1	4.00 number of incompatibilities STANDARD_DEVIATION 0.87
LDL-c	98.45 mg/dl STANDARD_DEVIATION 36.61	97.65 mg/dl STANDARD_DEVIATION 36.79	103.81 mg/dl STANDARD_DEVIATION 36.03	90.00 mg/dl STANDARD_DEVIATION 37.53
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	44 Participants	128 Participants	42 Participants	42 Participants
Region of Enrollment Spain	44 participants	128 participants	42 participants	42 participants
Sex: Female, Male Female	11 Participants	35 Participants	12 Participants	12 Participants
Sex: Female, Male Male	33 Participants	93 Participants	30 Participants	30 Participants
Time in dialysis	37.86 months STANDARD_DEVIATION 29.97	33.22 months STANDARD_DEVIATION 26.82	32.95 months STANDARD_DEVIATION 26.16	28.61 months STANDARD_DEVIATION 23.61
Total cholesterol	165.86 mg/dl STANDARD_DEVIATION 47.99	169.40 mg/dl STANDARD_DEVIATION 43.78	179.37 mg/dl STANDARD_DEVIATION 42.47	162.82 mg/dl STANDARD_DEVIATION 39.29
Transfusions	0.66 average number of transfusions/patient STANDARD_DEVIATION 1.27	0.78 average number of transfusions/patient STANDARD_DEVIATION 1.99	0.83 average number of transfusions/patient STANDARD_DEVIATION 2.12	0.85 average number of transfusions/patient STANDARD_DEVIATION 2.5
Triglycerides levels	184.26 mg/dl STANDARD_DEVIATION 114.93	197.60 mg/dl STANDARD_DEVIATION 105.83	209.69 mg/dl STANDARD_DEVIATION 109.01	199.31 mg/dl STANDARD_DEVIATION 91.99

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	12 / 44	17 / 42	18 / 42
serious Total, serious adverse events	8 / 44	5 / 42	12 / 42

Outcome results

Primary

Patients Treated With Insulin or Oral Antidiabetic Drugs

Time frame: 1 year

Population: Participant analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (NUMBER)
Tacrolimus With Rapid Steroid Withdrawal	Patients Treated With Insulin or Oral Antidiabetic Drugs	20 percentage of participants
Tacrolimus With Steroids Minimization	Patients Treated With Insulin or Oral Antidiabetic Drugs	15.4 percentage of participants
CsA With Steroid Minimization	Patients Treated With Insulin or Oral Antidiabetic Drugs	2.6 percentage of participants

p-value: 0.06Chi-squared

Primary

Primary Outcome Measure (Glucose Intolerance)

Glycemia \>=140 and \<200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.

Time frame: 1 year

Population: Participants included are those that did not develop NODAT based on not reporting the use of anti-diabetic drugs plus a fasting plasma glucose \<126 mg/dl .

Arm	Measure	Value (NUMBER)
Tacrolimus With Rapid Steroid Withdrawal	Primary Outcome Measure (Glucose Intolerance)	26.9 percentage of participants
Tacrolimus With Steroids Minimization	Primary Outcome Measure (Glucose Intolerance)	31.0 percentage of participants
CsA With Steroid Minimization	Primary Outcome Measure (Glucose Intolerance)	33.3 percentage of participants

p-value: 0.9Chi-squared

Primary

Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)

American Diabetes Association criteria (ADA) including an oral glucose tolerance test.

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end

Arm	Measure	Group	Value (NUMBER)
Tacrolimus With Rapid Steroid Withdrawal	Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	% of patients with NODAT	34.1 percentage of participants
Tacrolimus With Rapid Steroid Withdrawal	Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	% of patients without NODAT	65.9 percentage of participants
Tacrolimus With Steroids Minimization	Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	% of patients without NODAT	76.9 percentage of participants
Tacrolimus With Steroids Minimization	Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	% of patients with NODAT	23.1 percentage of participants
CsA With Steroid Minimization	Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	% of patients without NODAT	92.1 percentage of participants
CsA With Steroid Minimization	Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)	% of patients with NODAT	7.9 percentage of participants

p-value: 0.02Chi-squared

Secondary

Blood Pressure

Systolic pressure (mmHg)

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)	Dispersion
Tacrolimus With Rapid Steroid Withdrawal	Blood Pressure	135.36 mmHg	Standard Deviation 15.75
Tacrolimus With Steroids Minimization	Blood Pressure	133.97 mmHg	Standard Deviation 13.67
CsA With Steroid Minimization	Blood Pressure	136.28 mmHg	Standard Deviation 17.27

p-value: 0.8ANOVA

Secondary

Blood Pressure

Diastolic pressure (mmHg)

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)	Dispersion
Tacrolimus With Rapid Steroid Withdrawal	Blood Pressure	76.67 mmHg	Standard Deviation 8.93
Tacrolimus With Steroids Minimization	Blood Pressure	74.59 mmHg	Standard Deviation 9.83
CsA With Steroid Minimization	Blood Pressure	76.64 mmHg	Standard Deviation 10.27

p-value: 0.56ANOVA

Secondary

Changes of Carotid Intima-media Thickness Over Time

absolute difference between carotid intima-media thickness at study end versus baseline.

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)
Tacrolimus With Rapid Steroid Withdrawal	Changes of Carotid Intima-media Thickness Over Time	0.12 mm
Tacrolimus With Steroids Minimization	Changes of Carotid Intima-media Thickness Over Time	0.04 mm
CsA With Steroid Minimization	Changes of Carotid Intima-media Thickness Over Time	0.01 mm

p-value: 0.5ANOVA

Secondary

Lipidic Profile (Cholesterol)

Lipidic Profile (total cholesterol)

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)	Dispersion
Tacrolimus With Rapid Steroid Withdrawal	Lipidic Profile (Cholesterol)	169.05 mg/dl	Standard Deviation 30.57
Tacrolimus With Steroids Minimization	Lipidic Profile (Cholesterol)	178.24 mg/dl	Standard Deviation 33.64
CsA With Steroid Minimization	Lipidic Profile (Cholesterol)	168.89 mg/dl	Standard Deviation 33.38

p-value: 0.37ANOVA

Secondary

Lipidic Profile (HDL-c)

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)	Dispersion
Tacrolimus With Rapid Steroid Withdrawal	Lipidic Profile (HDL-c)	44.84 mg/dl	Standard Deviation 13.89
Tacrolimus With Steroids Minimization	Lipidic Profile (HDL-c)	49.29 mg/dl	Standard Deviation 16.9
CsA With Steroid Minimization	Lipidic Profile (HDL-c)	48.35 mg/dl	Standard Deviation 16.59

p-value: 0.45ANOVA

Secondary

Lipidic Profile (LDL-c)

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)	Dispersion
Tacrolimus With Rapid Steroid Withdrawal	Lipidic Profile (LDL-c)	94.00 mg/dl	Standard Deviation 27.04
Tacrolimus With Steroids Minimization	Lipidic Profile (LDL-c)	95.43 mg/dl	Standard Deviation 26.54
CsA With Steroid Minimization	Lipidic Profile (LDL-c)	88.65 mg/dl	Standard Deviation 25.73

p-value: 0.5ANOVA

Secondary

Lipidic Profile (Triglycerides)

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)	Dispersion
Tacrolimus With Rapid Steroid Withdrawal	Lipidic Profile (Triglycerides)	159.44 mg/dl	Standard Deviation 93.68
Tacrolimus With Steroids Minimization	Lipidic Profile (Triglycerides)	145.59 mg/dl	Standard Deviation 52.97
CsA With Steroid Minimization	Lipidic Profile (Triglycerides)	160.78 mg/dl	Standard Deviation 84.26

p-value: 0.66ANOVA

Secondary

Number of Antihypertensive Drugs Patients Reported Taking.

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEDIAN)
Tacrolimus With Rapid Steroid Withdrawal	Number of Antihypertensive Drugs Patients Reported Taking.	2 number of antihypertensive drugs
Tacrolimus With Steroids Minimization	Number of Antihypertensive Drugs Patients Reported Taking.	2 number of antihypertensive drugs
CsA With Steroid Minimization	Number of Antihypertensive Drugs Patients Reported Taking.	2 number of antihypertensive drugs

p-value: 0.8Kruskal-Wallis

Secondary

Percentage of Patients Using Acetylsalicylic Acid (ASA)

Time frame: 1 year

Population: Analysis population description: participants living with a functioning graft at study end.

Arm	Measure	Value (NUMBER)
Tacrolimus With Rapid Steroid Withdrawal	Percentage of Patients Using Acetylsalicylic Acid (ASA)	53.9 percentage of participants
Tacrolimus With Steroids Minimization	Percentage of Patients Using Acetylsalicylic Acid (ASA)	48.7 percentage of participants
CsA With Steroid Minimization	Percentage of Patients Using Acetylsalicylic Acid (ASA)	52.8 percentage of participants

p-value: 0.9Chi-squared

Secondary

Percentage of Patients Using Statins

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (NUMBER)
Tacrolimus With Rapid Steroid Withdrawal	Percentage of Patients Using Statins	56. percentage of participants
Tacrolimus With Steroids Minimization	Percentage of Patients Using Statins	61.5 percentage of participants
CsA With Steroid Minimization	Percentage of Patients Using Statins	73.7 percentage of participants

p-value: 0.17Chi-squared

Secondary

Proteinuria

Time frame: 1 year

Population: Participants analyzed: participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)
Tacrolimus With Rapid Steroid Withdrawal	Proteinuria	208 mg/day
Tacrolimus With Steroids Minimization	Proteinuria	241 mg/day
CsA With Steroid Minimization	Proteinuria	343.2 mg/day

p-value: 0.4ANOVA

Secondary

Rejection

Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.

Time frame: 1 year

Arm	Measure	Value (NUMBER)
Tacrolimus With Rapid Steroid Withdrawal	Rejection	11.4 percentage of participants
Tacrolimus With Steroids Minimization	Rejection	4.8 percentage of participants
CsA With Steroid Minimization	Rejection	21.4 percentage of participants

p-value: 0.07Chi-squared

Secondary

Renal Function

Estimated Glomerular Filtration Rate (ml/min/1.73 m\^2)

Time frame: 1 year

Population: Participants analyzed: Participants living with a functioning graft at study end.

Arm	Measure	Value (MEAN)
Tacrolimus With Rapid Steroid Withdrawal	Renal Function	51.9 ml/min/1.73 m^2
Tacrolimus With Steroids Minimization	Renal Function	47.4 ml/min/1.73 m^2
CsA With Steroid Minimization	Renal Function	44.6 ml/min/1.73 m^2

p-value: 0.2ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Patients Treated With Insulin or Oral Antidiabetic Drugs

Primary Outcome Measure (Glucose Intolerance)

Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)

Blood Pressure

Blood Pressure

Changes of Carotid Intima-media Thickness Over Time

Lipidic Profile (Cholesterol)

Lipidic Profile (HDL-c)

Lipidic Profile (LDL-c)

Lipidic Profile (Triglycerides)

Number of Antihypertensive Drugs Patients Reported Taking.

Percentage of Patients Using Acetylsalicylic Acid (ASA)

Percentage of Patients Using Statins

Proteinuria

Rejection

Renal Function