RecruitingPhase 4

Mechanism of SGLT2 Inhibition in the Kidney

Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary outcomes measure will be change in transcripts as assessed by single-cell RNA sequencing of kidney biopsy specimens obtained at study entry and after 6 months of study drug."
  • "Secondary outcomes include assessing the effects of canagliflozin on structural progression of DKD assessed by morphometric examination of kidney tissue specimens from the paired research biopsies."
  • "Additional secondary outcomes include measures of glomerular filtration rate (GFR) and renal plasma flow (RPF) as well as multiparametric kidney MRI."
  • "Imaging of the kidneys will be done as near to the time of each kidney biopsy as possible."
  • "Participants will be followed for potential adverse events for an additional two months post six-month biopsy."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether canagliflozin (INVOKANA) helps protect the kidneys in people with type 2 diabetes. It is for adults ages 18–80 who have had type 2 diabetes for at least 3 years. Participants take the drug for 6 months and have kidney scans and biopsies, which remove small samples of kidney tissue.

The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years. Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study: Consent and Screening: * Laboratory tests to determine baseline health * Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys Month 0: * Study entry kidney MRI (day 0) * Study entry kidney biopsy (within 30 days of MRI) * Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supply Month 3: * Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication * Review of systems Month 6: * Follow-up kidney MRI * Follow-up kidney biopsy Study participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs). Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–80 years old.
  • You have had type 2 diabetes for at least 3 years.
  • Your estimated kidney filtering rate (eGFR) is above 45 and below 90.
  • Your urine albumin-to-creatinine ratio, a measure of protein in urine, is below 3,000 mg/g.
  • You agree to join after the study is fully explained.
  • If you take a RAAS inhibitor, you have taken the highest dose you can tolerate for at least 3 months.
  • If you take a GLP-1 receptor agonist, a type of diabetes drug, you have taken it for at least 3 months.
  • You meet current medical guidelines for taking SGLT2 inhibitors, the drug group that includes canagliflozin.

Who can't join

  • You have certain serious liver, heart, blood vessel, lung, digestive, or long-term illnesses that could affect safety or kidney testing.
  • You have kidney disease not caused by diabetes, unexplained blood in urine, certain kidney or urinary tract problems, or only one kidney. Kidneys that are too small or differ too much in size also rule you out.
  • You have certain severe types of high blood pressure, or blood pressure of 150 or higher for the top number or 90 or higher for the bottom number.
  • You have used SGLT2 inhibitors, or take steroids, drugs that weaken the immune system, other study drugs, lithium, digoxin, or drugs called UGT enzyme inducers.
  • You are pregnant or plan pregnancy within 3 years. Those who could become pregnant must use effective birth control and have pregnancy tests before joining and every 2 months.
  • You are allergic to canagliflozin, iodine, iodine-containing scan dye, or shellfish. You have a bleeding disorder or cannot safely stop blood-thinning drugs for a kidney biopsy.
  • You have certain blood test results outside the study’s limits, including low red blood cells or platelets, abnormal clotting tests, or high blood urea nitrogen, a waste product.
  • Your body mass index (BMI) is 45 or higher; you have had a fracture linked to weak bones or a lower-limb amputation; or a condition could prevent you from giving informed consent or following study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Aged 18-80 years. * The lower age limit was set so renal function test results would not reflect changes associated with growth. * Diagnosis of type 2 diabetes for ≥ 3 years. * Estimated GFR \>45 and \< 90 ml/min/1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009) * A screening urinary albumin-to-creatinine ratio \<3000 mg/g. * Willingness to participate after receiving a thorough explanation of the study. * Participants receiving a RAAS inhibitor must have been receiving the drug at maximum tolerable dose for at least 3 months prior to the study baseline examination. * Participants receiving a GLP-1 receptor agonist must have been receiving the drug for at least 3 months prior to the study baseline examination. * Participants must meet the current clinical guidelines for prescribing SGLT2 inhibitors, to maintain FDA-approved standards Exclusion Criteria: * Clinically significant disorders of the liver \[cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg/dl), active or uncontrolled cardiovascular disease, symptomatic peripheral vascular disease, (i.e. intermittent claudication), pulmonary diseases (including uncontrolled asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels ≤30 percent in women or ≤35 percent in men. * Prior and ongoing treatment with SGLT2 inhibitors * Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg) * Hematuria of unknown etiology. * Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate. * Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus \[SLE\], cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment. * Currently receiving a drug regimen that includes steroids, immunosuppressants, or investigational new drugs not associated with this trial. * Pregnancy. * SGLT2 inhibitors are not recommended during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies.. Women of childbearing potential must have a negative pregnancy test prior to entry and every 2 months during the study and agree to using an effective form of contraception throughout the study, such as the oral contraceptive pill or an intrauterine device. Women who are planning a pregnancy in the next three years will be excluded. * Known hypersensitivity to canagliflozin or iodine. * Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted since kidney biopsies cannot be performed safely in these individuals. * Massive obesity with body mass index ≥45 kg/m². * Kidney biopsies are more technically difficult with massive obesity. * Allergy to iodine-containing contrast material or shellfish. * Non-diabetic kidney disease - based on clinical history or kidney biopsy examination. * History of osteoporotic fracture. * History of lower-limb amputation irrespective of etiology * Conditions likely to interfere with informed consent or compliance with the protocol. * Known solitary kidney * Size of one or both kidneys on ultrasound \< 9 cm (small kidney size is concerning for renal atrophy due to underlying kidney disease) or \> 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter * Current use of UGT enzyme inducters, lithium, and digoxin * Blood urea nitrogen (BUN) \> 80 gm/dL * INR \> 1.4 (a) * PTT \> 35 seconds (a) * Platelet count \< 100,000 uL (a) * Hemoglobin (Hgb) \< 10 mg/dL (a) * Hydronephrosis or other important renal ultrasound findings such as significant stone disease 1. Inclusion possible after this has been obtained within range

Study sites (1)

MI