In order to achieve these objectives, clinical data and blood sample results obtained through the MUHC LEGACY Biobank (directed by Dr. Evelyne Vinet) will be analysed. The objective of the LEGACY Biobank (the "Bank") is the conservation of blood samples; more specifically, plasma, sera, and crude white cell pellet and clinical data ("material/data") collected from an international multi-centre prospective cohort of pregnant women with systemic lupus erythematosus (SLE).

Systemic Lupus Erythematosus

Pregnancy Complications

James G, Witten D, Hastie T, Tibshirani R. An Introduction to Statistical Learning—With Applications in R. New York: Springer; 2013.

McGill University Health Centre

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

Fetal death, neonatal death, preterm delivery or termination of pregnancy, and small for gestational age neonate confirmed by chart review and autopsy report.

The Adherence to Refills and Medications Scale (ARMS), a validated self-reported questionnaire developed for patients with chronic disease with low literacy, measures ASA adherence. A self-reported aspirin adherence questionnaire consisting of 3 to 6 questions about the use of aspirin during current pregnancy measures ASA use. A visual analogue scale from 0 to 10 measures frequency of ASA ingestion. Change in ASA use will be measured by the questionnaires. Frequencies of dosage of ASA will also be measured.

Baseline covariates such as lupus anticoagulant antibodies, a subtype of anticoagulant antibodies, Antiphosphatidylserine/prothrombin antibodies (aPS/PT), antihypertensive use, disease activity, platelet levels will be measured and defined by the physician-in-charge. Nephritis history, race/ethnicity, nulliparity, maternal age, pre-gestational diabetes, obsesity (BMI above 30) and medication use (corticosteroids, antimalarials, immunosuppressive and low-dose aspirin) will be characterized.
Measures for disease activity include the SLE Pregnancy Disease Activity Index (SLEPDAI), a widely-recognized adaptation of the validated SLE Disease Activity Index, reflects disease activity in pregnancy context.

Positive results for Antiphosphatidylserine/prothrombin antibodies (aPS/PT) and and lupus anticoagulant results in pregnant women with SLE with and without adverse pregnancy outcomes

Information will be kept between investigators.

Evelyne Vinet

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Duke University

University of California, Los Angeles

Dalhousie University

Hanyang University

Hospital for Special Surgery, New York

Johns Hopkins University

Monash University

New York University

Oklahoma Medical Research Foundation

University of North Carolina

Temple University

University of Alabama at Birmingham

University of Birmingham

University of Calgary

University of California

University of Copenhagen

University of Manitoba

University of Michigan

University of Toronto

NYU Langone Health

University of British Columbia

National Institute of Medical Science & Nutrition

Laval University

University Health Network, Toronto

At the baseline visit, after having responded to the questionnaire, participants in the education arm will be given the patient educational tool.

Subjects in the standard of care arm will not receive the patient educational tool. If participants ask specific questions on pregnancy complications and/or preeclampsia, the clinicians will provide relevant information as they judge appropriate, but without handing out the patient educational tool.

Pre-Eclampsia

Systemic Lupus

This tool is a modified version of the patient educational sheet elaborated and validated by You et al in collaboration with the Preeclampsia Foundation. This patient educational sheet graphically defines preeclampsia and its. A licensing agreement has been obtained from the Preeclampsia Foundation, with the rights to modify the educational tool for this RCT. The SLE-specific educational tool will consist in a sheet displaying the previously developed patient educational form on the recto. However, on the verso of the sheet, SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.

Patient Educational Tool

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Aspirin Patterns of Use and Adherence for Prevention of Preeclampsia in SLE Pregnancies

Responses to preeclampsia knowledge questionnaire will be compared at baseline (before randomization) and at second trimester. Questionnaire includes 20 questions, both closed and open ended, regarding preeclampsia implications, symptoms, role of aspirin for its prevention and actions that should be taken if patient experiences preeclampsia symptoms. The questionnaire total score ranges from 0 to 20, with higher score indicating better preeclampsia knowledge. The questionnaire will be scored by 2 independent investigators calculating the number of correct responses.
Subjects will be randomized in a 1:1 ratio to either patient educational tool or standard of care. SLE specific educational tool consists of sheet displaying the previously developed patient education form on recto. On verso SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.

At each 4 pregnancy time points, up to and including 12 weeks gestation (baseline), between 20 - 24 weeks (2nd trimester), between 30-34 weeks (3rd trimester) and at 8 to 12 weeks after delivery, patient self-reported ASA use (i.e. current user versus non-user) will be recorded for all participants.

In participants, the Adherence to Refills and Medications Scale (ARMS) will measure changes in aspirin adherence at baseline and second trimester visit. The ARMS is a validated self-reported questionnaire developed for patients with chronic diseases with low literacy. It includes 12 short and simple questions, each scored 1 ("always") to 4 ("never"), and the total ranges from 12 to 48, with lower scores indicating higher levels of reported adherence. Investigator will define adherence as a continuous variable using the ARMS score and compare the between-group difference using a logarithmic transformation of ARMS scores at the baseline and 2rd trimester visits.

Changes in the visual analogue scale measuring ASA adherence from baseline to second trimester visit.
On a scale of 0 to 10 where 0 is never and 10 is always, patient-reported adherence to aspirin use will be measured.

Seventy five (75) CKD patients in different stages will be included in our study from Nephrology unit, Internal Medicine department, Assuit University Hospital

twenty five (25) age and sex matched apparently healthy individuals will be enrolled as controls

Evaluation of Early Inflammatory Process in CKD

Studying the Relationship Between Mean Platelet Volume and Neutrophil/ Lymphocyte Ratio With Inflammation and Proteinuria in Chronic Kidney Disease

The relationship between (MPV) and (NLR) with inflammation and proteinuria in patients with CKD at stage 2 , 3 and 4 by simple parameters.

walaa soliman

assuit

Assiut University

Metabolic Syndrome

Endothelial Dysfunction

Eplerenone

Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg

Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg

Effect of Eplerenone on Endothelial Function in Metabolic Syndrome

Prospective and Open Label Study With Blind End Point Evaluation on the Effect of Mineralocorticoid Receptor Inhibition on Endothelial Function of the Micro- and Macrovasculature in Patients With Metabolic Syndrome

Roland E. Schmieder

Prof. Dr. med.

University of Erlangen-Nürnberg Medical School

Patients receive cyclosporin (dose-adjusted to pre-established targets) as immunosuppressive calcineurin inhibitor (CNI) and Diabetes Education / Management (therapeutic adjustment to target American Diabetes Association (ADA) criteria)

Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)

Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)

Cyclosporin

Tacrolimus

Total

Sex: Female, Male

The count of participants with freedom from insulin therapy post transplant is reported.

Freedom From Insulin Therapy Post Transplant

Values of ≥60 ml/min/1.73 m^2 are considered optimal; ≥30-59 ml/min/1.73 m^2 are indicative of successful graft function; lower values are indicative or graft dysfunction.

Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation

Count of participants alive at one year post transplantation

Patient Survival at One Year Post Transplantation

Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation

Patients receive cyclosporin (Neoral; dose-adjusted to pre-established targets) as immunosuppressive calcineurin inhibitor (CNI) and Diabetes Education / Management (therapeutic adjustment to target American Diabetes Association (ADA) criteria)

Patients receive tacrolimus (Prograf; dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)

Overall Study

Stephan Busque, MD

Kidney Transplant

Diabetes Mellitus, Type 2

Diabetic Nephropathy

Dose adjustment to pre-established targets

therapeutic adjustment to target ADA criteria

'Diabetes Education / Management'

Stanford university Hospital and Clinics

Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

Randomized Open Label Study Comparing the Metabolic Control of Kidney Transplant Recipients With Type 2 Diabetes Receiving Either Prograf or Neoral as Part of a ATG Induction, Prednisone Free and Monitored MMF Immunosuppressive Regimen.

nephritis/obesity

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

ASA Patterns for Prevention of Preeclampsia in SLE Pregnancies

Studying the Relationship Between Mean Platelet Volume and Neutrophil/ Lymphocyte Ratio With Inflammation and Proteinuria in Chronic Kidney Disease

Effect of Eplerenone on Endothelial Function in Metabolic Syndrome

Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

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