Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial

Abbate, Manuela; Perico, Norberto; Ruggenenti, Piero; Remuzzi, Giuseppe; Rota, Stefano; Trillini, Matias; Ruggiero, Barbara; Aparicio, Maria Carolina; Prandini, Silvia; Cugini, Daniela; Gherardi, Giulia; Podestà, Manuel Alfredo; Trevisan, Roberto; Corsi, A.; Bossi, Antonio; Parvanova, Aneliya; Iliev, Ilian; Yakymchuk, Svitlana; Lecchi, V.; Belviso, Antonio; Mangili, Ruggero; Rubis, Nadia; Calini, Wally; Diadei, Olimpia; Ene-Iordache, Bogdan; Carminati, Sergio; Martinetti, Davide; Giuliano, Giovanni; Perna, Annalisa; Peraro, Francesco; Russo, Angela; Gaspari, Flavio; Carrara, Fabiola; Ferrari, Silvia; Stucchi, Nadia; Cannatà, Antonio; Boccardo, Paola; Peracchi, S.; Borst, Martin H. de; Bettoni, Serena; Cattaneo, Irene; Franchina, Davide G.; Phan, Haian Ha; Igiraneza, Grace; Kaucsár, Tamás; Lima, Sergio Luis; Lunney, Meg; Tran, Hoanh

doi:10.1016/s2213-8587(17)30359-5

Cited by 27 publications

(23 citation statements)

References 28 publications

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“…Smoking has been associated with incident albuminuria in the general population and with albuminuria in systematic reviews of type 2 DM [14,15]. Lower sodium ingestion is associated with lower albuminuria and in clinical trials, lowering sodium ingestion decreased albuminuria in DKD [16]. Specifically, the dietary sodium restriction increased the anti-albuminuric effect of RAS blockade, which is relevant for our study [16].…”

Section: Discussionmentioning

confidence: 78%

“…Lower sodium ingestion is associated with lower albuminuria and in clinical trials, lowering sodium ingestion decreased albuminuria in DKD [16]. Specifically, the dietary sodium restriction increased the anti-albuminuric effect of RAS blockade, which is relevant for our study [16]. In this regard, a lower potassium intake may facilitate achieving an optimal dosing of RAS blockers [17].…”

Section: Discussionmentioning

confidence: 88%

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Gender, Albuminuria and Chronic Kidney Disease Progression in Treated Diabetic Kidney Disease

Fernández-Fernández

Mahíllo

Sánchez-Rodríguez

et al. 2020

JCM

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Background: Women are reported to have a lower incidence of renal replacement therapy, despite a higher prevalence of chronic kidney disease (CKD). Aim: To analyze diabetic kidney disease (DKD) progression in men and women. Methods: Prospective cohort: n = 261, 35% women, new consecutive nephrology DKD referrals. Results: Women smoked less and better complied with the dietary phosphate and sodium restrictions. Despite a less frequent nephrology referral, women had lower baseline albuminuria. Over a 30 ± 10-month follow-up, albuminuria decreased in women and the estimated glomerular filtration rate (eGFR) loss was slower than in men. However, the percentage of rapid progressors was similar in both sexes. The best multivariate model predicting rapid progression in men (area under curve (AUC) = 0.92) and women differed. Albuminuria and fractional excretion of phosphate (FEphosphate) were part of the men multivariable model, but not of women. The AUC for the prediction of rapid progression by albuminuria was higher in men than in women, and the albuminuria cut-off points also differed. In women, there was a higher percentage of rapid progressors who had baseline physiological albuminuria. Conclusions: Female DKD differs from male DKD: albuminuria was milder and better responsive to therapy, the loss of eGFR was slower and the predictors of rapid progression differed from men: albuminuria was a better predictor in men than in women. Lifestyle factors may contribute to the differences.

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Section: Discussionmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 88%

Gender, Albuminuria and Chronic Kidney Disease Progression in Treated Diabetic Kidney Disease

Fernández-Fernández

Mahíllo

Sánchez-Rodríguez

et al. 2020

JCM

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“…The impact of active vitamin D on albuminuria has reported in a meta-analysis by de Borst et al [ 47 ]. IDEAL-2, however, differs from recent clinical trials that have examined the impact of active vitamin D treatment on albuminuria in DKD [ 28 , 48 ]. Most studies have examined the impact of paricalcitol on albuminuria.…”

Section: Discussionmentioning

confidence: 99%

“…IDEAL-2 includes longer treatment with active vitamin D (26 weeks) than previous clinical trials, essential for assessing the durability of response. It has been proposed that active vitamin D would be a useful add-on treatment to those who are refractory to salt restriction [ 48 ]. IDEAL-2 does not stipulate any salt restriction (usually a challenge for patients) or examine in detail the impact of salt intake on urinary albumin.…”

Section: Discussionmentioning

confidence: 99%

Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial

Taheri

Asim

Malki

et al. 2018

Trials

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BackgroundThe prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. T2DM is associated with serious macro- and microvascular complications. In particular, diabetic kidney disease (DKD), which begins with excessive urinary albumin excretion, has a significant impact on affected individuals and is costly to healthcare services. Inhibition of the renin–angiotensin–aldosterone system (RAAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) significantly reduces albuminuria in diabetes, but this effect is not observed in all those treated. Active vitamin D analogues have been observed to be reno-protective through inhibition of RAAS in animal and human studies. Therefore, it can be hypothesised that an active vitamin D analogue will have an additional benefit to ACEI/ARB treatment for albuminuria reduction in DKD.MethodsThe planned study is an ongoing non-blinded randomised controlled parallel-group trial examining the impact, in individuals with T2DM, of the addition of bioactive vitamin D (calcitriol) to RAAS inhibition treatment using ACI or ARB on urinary albumin excretion over a period of 26 weeks. The primary outcome measure is the urinary albumin creatinine ratio. It is planned for the study to recruit 320 participants. Other outcome measures of interest include 24-h urine albumin (24 h UA) excretion, estimated glomerular filtration rate (eGFR), blood pressure and quality of life. Safety will be assessed throughout.DiscussionIf the addition of calcitriol to RAAS inhibition with ACEI or ARB safely results in a significant reduction in albuminuria, the study adds to the body of evidence supporting a role for vitamin D in reno-protection, will inform clinical practice and could result in significant reduction of healthcare costs associated with DKD.Trial registrationISRCTN, ISRCTN86739609. Registered on 7 June 2017. ClinicalTrials.gov, NCT03216564. Registered on 13 July 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2616-5) contains supplementary material, which is available to authorized users.

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“…The combination of vitamin D analog with an ARB has been shown to have synergetic effects on RAAS blockade, thereby boosting its overall therapeutic effect ( 242 , 243 ). However, as there is currently no recommended clinical dosage of vitamin D analog for use in DKD, long-term and prospective clinical data is required to assess its safety and efficacy ( 244 , 245 ). Retinoic acids (RAs) are vitamin A derivatives and appear to have renoprotective effects on various murine nephropathy such as HIV-associated nephropathy (HIVAN) ( 246 ) and PAN-induced nephrotic rats ( 247 ).…”

Section: Introductionmentioning

confidence: 99%

Proteinuric Kidney Diseases: A Podocyte's Slit Diaphragm and Cytoskeleton Approach

Nissaisorakarn

Husain

et al. 2018

Front. Med.

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Proteinuric kidney diseases are a group of disorders with diverse pathological mechanisms associated with significant losses of protein in the urine. The glomerular filtration barrier (GFB), comprised of the three important layers, the fenestrated glomerular endothelium, the glomerular basement membrane (GBM), and the podocyte, dictates that disruption of any one of these structures should lead to proteinuric disease. Podocytes, in particular, have long been considered as the final gatekeeper of the GFB. This specialized visceral epithelial cell contains a complex framework of cytoskeletons forming foot processes and mediate important cell signaling to maintain podocyte health. In this review, we will focus on slit diaphragm proteins such as nephrin, podocin, TRPC6/5, as well as cytoskeletal proteins Rho/small GTPases and synaptopodin and their respective roles in participating in the pathogenesis of proteinuric kidney diseases. Furthermore, we will summarize the potential therapeutic options targeting the podocyte to treat this group of kidney diseases.

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Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial

Cited by 27 publications

References 28 publications

Gender, Albuminuria and Chronic Kidney Disease Progression in Treated Diabetic Kidney Disease

Gender, Albuminuria and Chronic Kidney Disease Progression in Treated Diabetic Kidney Disease

Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial

Proteinuric Kidney Diseases: A Podocyte's Slit Diaphragm and Cytoskeleton Approach

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