Nephrology

Researchers are investigating a new, non-invasive method to monitor kidney function after transplantation using advanced non-contrast Magnetic Resonance Imaging (MRI). This study aims to create individualized baselines for transplanted kidneys by scanning donors before donation, allowing earlier detection of kidney problems compared to current blood tests or biopsies. It includes both donor-recipient pairs and recipients without donor data, primarily from deceased donors, to evaluate MRI's ability to track kidney health over time. Participants are divided into two main groups: one where donors undergo pre-transplant MRI to establish a personalized baseline for their kidney before transplant, and recipients are followed post-transplant to compare function against this baseline; the other group includes recipients without donor MRI data to validate MRI's standalone monitoring ability. The study also assesses body composition and metabolic health to better understand their impact on transplant kidney function. During the study, participants will undergo scheduled non-contrast MRI scans alongside clinical, laboratory, and body composition assessments. Data such as serum creatinine, eGFR, and biopsy results when available will be collected to correlate with MRI findings. The main outcome is the diagnostic accuracy of MRI for detecting transplant kidney rejection and dysfunction over up to five years. Approximately 1000 participants will be enrolled to provide robust data for developing a precise, individualized monitoring tool for kidney transplant patients.

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are evaluating an experimental treatment involving the infusion of allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC) directly into the renal artery to determine its safety and potential to reduce inflammation and treat rejection in adult kidney transplant recipients. The study focuses on those with subclinical rejection confirmed by biopsy, including antibody-mediated and cellular rejection. This phase 1 study aims to better understand this novel therapy's impact on kidney transplant rejection. Participants are divided into two groups receiving different doses of the treatment: one group receives a low dose (1 x 10^5 cells/kg) and the other a high dose (5 x 10^5 cells/kg) of allo-A-MSC via a single intra-arterial infusion, with the high dose infused over five minutes. Both groups consist of adults with stable renal function and biopsy-proven rejection within three months prior to enrollment. Throughout the study, participants will be closely monitored for adverse events over one year and assessed for worsening kidney allograft rejection 28 days after infusion. Researchers will evaluate kidney function, immune response, and safety through clinical and laboratory assessments. The study duration includes follow-up visits to ensure participant safety and to gather data on the treatment's effects in kidney transplant rejection management.

Researchers are evaluating the safety and effectiveness of two different immunosuppressive drug regimens in children and young adults who have received a kidney transplant. This pediatric study focuses on comparing a treatment combining belatacept and sirolimus with a standard regimen of tacrolimus and Mycophenolate Mofetil (MMF). The trial aims to improve transplant outcomes and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Participants will be randomly assigned within 24 hours after their transplant to one of two groups. One group will receive antithymocyte globulin (ATG), a steroid taper, belatacept infusions, a short tacrolimus bridge, and then switch to sirolimus around one month after transplant. The other group will receive ATG, a steroid taper, tacrolimus, and MMF. Belatacept is given intravenously on a scheduled timeline up to 24 months, and sirolimus dosing depends on participant weight. During the 12 to 24 months of follow-up, participants will have regular assessments including blood tests for donor-specific antibodies and kidney function, as well as biopsies to detect graft rejection and infections. Researchers will monitor adverse events and track outcomes such as infection rates and transplant complications. The study includes detailed lab monitoring and aims to measure the incidence of transplant-related complications up to 96 weeks post-transplant.

Researchers are studying how alloreactive memory B lymphocytes (Bmem) affect kidney transplant rejection in patients sensitized to HLA antigens. This observational study focuses on understanding the diversity and behavior of these B cells in patients awaiting kidney transplantation, especially those with different levels of immune sensitization. The goal is to improve assessment of immunological risk and develop better prevention strategies for humoral rejection by identifying key markers of harmful immune responses. Participants include three groups of patients monitored at Rouen University Hospital: those highly sensitized with broad HLA antibody repertoires, those moderately sensitized with more limited antibody profiles, and controls with no known immunizing events. At enrollment, a single 50 ml blood sample will be collected to analyze the B cells' clonality, phenotype, and gene expression using advanced RNA sequencing techniques targeting specific HLA alleles. During the study, researchers will measure the heterogeneity of alloreactive Bmem and assess their phenotypic, transcriptional, and clonal characteristics. The study aims to provide foundational knowledge about Bmem biology and identify markers that could help predict transplant rejection risk. All data collection occurs at the enrollment visit, with no further interventions, and participation involves routine blood sampling and analysis under medical supervision.

Researchers are studying whether taking alpha-blockers before flexible ureterorenolithotripsy helps in the easier placement of a ureteral access sheath during kidney stone surgery. This phase 4 randomized trial involves adults diagnosed with nephrolithiasis who need flexible ureteroscopy. The goal is to see if alpha-blockers improve surgical success and reduce the need for additional procedures while monitoring safety outcomes like ureteral injuries. Participants will be randomly assigned to one of two groups. One group will take an oral alpha-blocker (such as tamsulosin 0.4 mg) once daily for seven days before surgery to relax the ureteral muscles and assist sheath insertion. The other group will undergo the same surgery without preoperative alpha-blockers. Both groups will follow the same surgical protocols. During the study, participants will have their surgery and be assessed for successful ureteral sheath placement during the procedure. Researchers will also track any ureteral injuries and the need for further surgical interventions. The primary measure is the rate of successful sheath insertion without needing a second procedure. The study will include visits and monitoring before, during, and after the surgery, with total participation lasting through the surgical and immediate perioperative period.

Alport syndrome is a hereditary type IV collagen disease that typically causes kidney failure early in life. This observational study investigates whether various medications can delay disease progression, postpone kidney failure, and improve life expectancy compared to untreated relatives. The study began as a European registry in 2006 and has expanded globally as "Alport XXL" through the International Alport Alliance, focusing on early therapy outcomes in young patients using ACE-inhibitors, Angiotensin-receptor blockers, or their combination. The study collects data on patients at different disease stages, from early microscopic hematuria to kidney failure, to assess the effectiveness of early medication initiation. Patients are grouped by treatment status and disease severity, including untreated relatives and those receiving therapy at various stages. The registry records detailed clinical data, including genetic information, urine albumin levels, kidney function, and medication doses, in a strictly observational manner without intervening in treatment decisions. Participants provide retrospective and prospective data through standardized questionnaires at baseline and follow-up visits. Data collected include kidney function tests, blood pressure, hearing loss, eye involvement, and adverse events. Researchers measure outcomes such as age at kidney failure, life expectancy, kidney function decline, and changes in urinary albumin. The study aims to observe long-term effects of therapies until 2037, supporting improved understanding of treatment timing and effectiveness in Alport syndrome.

Researchers are evaluating the effectiveness, safety, and tolerability of VX-880 in adults aged 18 to 65 who have Type 1 Diabetes and have received a kidney transplant. The study focuses on participants who have been insulin-dependent for at least 5 years and are on a stable immunosuppression regimen. This phase 3 clinical trial aims to understand how VX-880 impacts insulin independence and blood sugar control in this specific group. Participants will receive VX-880, a biological treatment infused into the hepatic portal vein. The study will monitor the proportion of participants who become insulin independent one year after the infusion. Secondary measures include maintaining insulin independence for at least one year, changes in glycosylated hemoglobin (HbA1c) levels, and tracking any adverse events throughout the study, which may last up to two years. During the study, participants will use a continuous glucose monitor (CGM) before and throughout the trial to track blood sugar levels consistently. Researchers will assess insulin independence, safety, and tolerability by observing adverse events and changes in blood sugar control. The study involves regular visits and monitoring over a period extending to two years to evaluate long-term outcomes and treatment effects.

Researchers are comparing two types of ultrasound-guided nerve blocks to manage pain during and after open nephrectomy surgery in cancer patients. The study aims to evaluate the effectiveness of the external oblique intercostal block versus the subcostal transversus abdominis plane block in providing pain relief. Open nephrectomy can cause severe immediate and chronic pain, and regional anesthesia techniques are used to reduce opioid use and improve patient comfort. Participants are divided into three groups: one receives the oblique subcostal transversus abdominis plane block, another receives the external oblique intercostal block, and the control group receives intravenous morphine after general anesthesia induction. Both nerve blocks involve injecting bupivacaine guided by ultrasound, aiming to cover the nerves supplying the surgical area. General anesthesia is maintained with standard medications during surgery. During the study, pain levels will be assessed 24 hours post-surgery alongside opioid and morphine consumption, heart rate, arterial pressure, time until additional pain relief is needed, and any complications. Monitoring lasts through surgery and up to 24 hours after. Participants will be closely evaluated for pain management effectiveness and safety throughout the study period.

Researchers are studying a new surgical method called the off-clamp sutureless technique for removing small kidney tumors less than 7 cm. This approach aims to preserve kidney function by avoiding clamping of the renal artery and using special techniques to control bleeding instead of traditional stitching. Current evidence mainly comes from smaller, retrospective studies focused on tumors smaller than 4 cm, so this study seeks to provide stronger data for larger or more complex tumors. The study involves patients undergoing robot-assisted partial nephrectomy using the off-clamp sutureless technique. During surgery, the renal artery is not clamped, and the tumor is removed with a small margin. Bleeding is controlled with electrocautery and hemostatic agents instead of sutures. This approach is designed to minimize damage to healthy kidney tissue and simplify the surgical process. Participants will be monitored for kidney function three months after surgery, measuring glomerular filtration rate (GFR) in both kidneys. Researchers will also track complications within one week after surgery and measure blood loss during the operation. The study includes detailed imaging and assessments before and after surgery to evaluate safety and effectiveness. The total participation period includes surgery and follow-up visits to assess recovery and kidney health.