[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439707":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sodium bicarbonate","EXPERIMENTAL","Oral sodium bicarbonate at a dose of 0.5 mEq\u002Fkg-lean body weight\u002Fday",[13],"Drug: Sodium bicarbonate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Oral placebo at a dose of 0.5 mEq\u002Fkg-lean body weight\u002Fday",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral sodium bicarbonate at 0.5 mEq\u002Fkg-lean body weight\u002Fday",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo at 0.5 mEq\u002Fkg-lean body weight\u002Fday",[15],[30],{"name":31,"affiliation":32,"role":33},"Jessica Kendrick, MD MPH","University of Colorado Denver | Anschutz","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","3037244837","jessica.kendrick@ucdenver.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-104.83192,39.72943,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":58},"Jessica Kendrick","303-724-4837","jessica.kendrick@cuanschutz.edu",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62],{"name":63,"class":64},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100439707","phase-4-effect-of-alkali-therapy-on-vascular-and-graft-function-in-kidney-transplant-recipients-100439707",false,"NCT05005793","Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients","Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant","Inclusion Criteria:\n\n* Age 18-80 years\n* Serum bicarbonate 16-24 mEq\u002FL on 2 separate measurements (at least 1 day apart)\n* Kidney transplant received 1 year prior to randomization\n* eGFR ≥ 45 ml\u002Fmin\u002F1.73m2 by CKD-EPI equation\n* Blood pressure \\\u003C130\u002F80 mm Hg prior to randomization\n* BMI \\\u003C 40 kg\u002Fm2 (FMD measurements can be inaccurate in severely obese patients).\n* Able to provide consent\n* Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen)\n* Stable immunosuppression regimen for at least three months prior to randomization\n* Stable anti-hypertensive regimen for at least one month prior to randomization\n* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).\n\nExclusion Criteria:\n\n* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year\n* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)\n* Uncontrolled hypertension\n* Serum potassium \\\u003C 3.3 or ≥ 5.5 mEq\u002FL at screening\n* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months\n* Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)\n* Factors judged to limit adherence to interventions\n* Current participation in another research study\n* Pregnancy or planning to become pregnant or currently breastfeeding\n* Chronic use of supplemental oxygen\n* Use of anticoagulants","ALL","18 Years","80 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.",[83,84,85],"Metabolic Acidosis","Kidney Transplant; Complications","Vascular Diseases","2025-05-28",{"date":88,"type":89},"2025-05-29","ACTUAL",{"date":91,"type":89},"2021-12-01",{"date":93,"type":77},"2026-08-31",{"name":5,"class":6},1]